Alzheimer DiseaseNCT04863495
Couples Lived Experience
An observational study of Alzheimer Disease and Dementia of Alzheimer Type, run by NYU Langone Health at 2 sites in United States.
Trial summary
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia of Alzheimer Type
- How many people
- 544 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2021to 16 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All genders, over the age of 65 that are community dwelling and in a committed relationship with an individual (also over the age of 65) that also agrees to participate in the study
Who may be able to join
- Community dwelling older adult aged 65 years or older
- Must speak English as the study measures are not validated in other languages.
- Must express intent to commit to ongoing participation in longitudinal study with assessments every 6 months for 3 years,
- Is part of a couple and their spouse/partner is also willing to participate in the project. All couples, regardless of sexual orientation or gender preference are eligible to participate
- Both members of the couple must cohabitate at the time of enrollment.
- Must have stable internet connection and capability to stream video with audio.
- A subset of the longitudinal study participants (selected at random) will be invited to be participate in a focus group upon completion of the last (3 year) quantitative assessment. These participants must be willing to have their comments recorded.
Who cannot join
- Any individual with a prior diagnosis of schizophrenia or other psychotic disorder.
- Individual is unable to complete the informed consent process
- Any individual with a prior diagnosis of a chronic disabling medical condition that would make it impossible to participate in a focus group via Zoom or WebEx.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Bedford, Massachusetts, 01730
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Multi-Center Observational Study of Couples Across the Trajectory of Dementia
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Day 0
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 6
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 12
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 18
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 24
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 30
Score on Geriatric Depression Scale (GDS-15)
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Measured: Month 36
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Day 0
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 6
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 12
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 18
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 24
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 30
Score on Beck Anxiety Inventory (BAI) Report
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Measured: Month 36
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Day 0
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 6
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 12
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 18
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 24
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 30
Score on Physical Health Questionnaire
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Measured: Month 36
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Day 0
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 6
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 12
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 18
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 24
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 30
Score on EuroQol Questionnaire Global quality of life
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Measured: Month 36
Number of participants with status change
Status changes include but are not limited to residential care placement, move to live with another relative, death
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start19 Apr 2021
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mary Mittelman, DrPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863495
- Sponsor's protocol ID
- 19-01966
- Status last verified
- Feb 2026
- First submitted
- 26 Apr 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
Mittelman MS, O'Connor MK, Donley T, Epstein-Smith C, Nguyen A, Nicholson R, Salant R, Shirk SD, Stevenson E. Longitudinal study: understanding the lived experience of couples across the trajectory of dementia. BMC Geriatr. 2021 Oct 15;21(1):558. doi: 10.1186/s12877-021-02503-4.
PubMed 34654375
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Study of Couples Across the Trajectory of Dementia
- ClinicalTrials.gov ID
- NCT04863495
- Acronym / sponsor ID
- 19-01966
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All genders, over the age of 65 that are community dwelling and in a committed relationship with an individual (also over the age of 65) that also agrees to participate in the study
Key inclusion criteria (7 listed)
- Community dwelling older adult aged 65 years or older
- Must speak English as the study measures are not validated in other languages.
- Must express intent to commit to ongoing participation in longitudinal study with assessments every 6 months for 3 years,
- Is part of a couple and their spouse/partner is also willing to participate in the project. All couples, regardless of sexual orientation or gender preference are eligible to participate
- Both members of the couple must cohabitate at the time of enrollment.
Key exclusion criteria (3 listed)
- Any individual with a prior diagnosis of schizophrenia or other psychotic disorder.
- Individual is unable to complete the informed consent process
- Any individual with a prior diagnosis of a chronic disabling medical condition that would make it impossible to participate in a focus group via Zoom or WebEx.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score on Geriatric Depression Scale (GDS-15)
Time frame: Day 0
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 6
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 12
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 18
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 24
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 30
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Geriatric Depression Scale (GDS-15)
Time frame: Month 36
This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Day 0
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 6
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 12
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 18
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 24
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 30
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Beck Anxiety Inventory (BAI) Report
Time frame: Month 36
This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.
Score on Physical Health Questionnaire
Time frame: Day 0
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 6
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 12
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 18
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 24
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 30
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on Physical Health Questionnaire
Time frame: Month 36
Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).
Score on EuroQol Questionnaire Global quality of life
Time frame: Day 0
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 6
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 12
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 18
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 24
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 30
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Score on EuroQol Questionnaire Global quality of life
Time frame: Month 36
This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"
Number of participants with status change
Time frame: Month 36
Status changes include but are not limited to residential care placement, move to live with another relative, death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 34654375Mittelman MS, O'Connor MK, Donley T, Epstein-Smith C, Nguyen A, Nicholson R, Salant R, Shirk SD, Stevenson E. Longitudinal study: understanding the lived experience of couples across the trajectory of dementia. BMC Geriatr. 2021 Oct 15;21(1):558. doi: 10.1186/s12877-021-02503-4.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Mittelman, DrPH principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia of Alzheimer Type, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Geriatric Depression Scale (GDS-15) (time frame: Day 0). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.