Cognitive ImpairmentPATH-MCINCT03043573
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
A study testing PATH-MCI and Supportive Therapy in people with Cognitive Impairment and Depression, run by Weill Medical College of Cornell University at 4 sites in United States.
Trial summary
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitive Impairment, Depression
- What is being tested?
- PATH-MCI and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2017to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amnestic MCI as defined by Albert et al
- Montgomery Asberg Depression Rating Scale (MADRS) greater than 7 and MADRS total less than 30
- Participants will be off antidepressants, cholinesterase inhibitors or memantine, or on a stable dosage for at least 12 weeks without any medical recommendation to adjust dosage in next 3 months (during treatment)
- Clinical Dementia Rating (CDR) = 0.5 at screening
- Subjects will have capacity to consent
Who cannot join
- Deemed to have a significant suicide risk as assessed by site PI and clinical team
- Deemed too unstable medically or neurologically to safely enroll in a research trial
- Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy. Requiring psychiatric hospitalization at baseline for safety.
- Current involvement in psychotherapy
- Lack of English fluency
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
Weill Cornell Medicine
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10461
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
White Plains, New York, 10605
About this study
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.
Read the detailed description
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. Supportive Therapy incorporates standard of care approaches by using non-specific techniques to provide a supportive environment and help patients to express their feelings \& focus on their strengths and abilities.
The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40 at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited. Both sites have shown feasibility of recruitment, randomization, retention, and assessment procedures for patients with MCI. Cornell has shown evidence of administration of PATH in this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15 in-office sessions in six months.
The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses and participant randomization status, will perform research assessments at baseline and at 6 (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.
There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the blood draws is to better understand whether response to psychotherapy treatment is affected by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents) and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry) will evaluate randomly selected sessions and rate the therapists' adherence and competence based on the PATH-MCI and ST Adherence Scales
The study partner will provide information about the treatment subject and participate in treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study partner, the investigators will collect the following data from the study partner: demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client Satisfaction Questionnaire).
- Conditions
- Cognitive Impairment, Depression
- Being tested
- PATH-MCI, Supportive Therapy
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH-MCIBehavioural
Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
Supportive TherapyBehavioural
Also called ST
ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
| Study group | Role | What they receive |
|---|---|---|
| PATH-MCI | Experimental | Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. Receives: Behavioral: PATH-MCI |
| Supportive Therapy | Active comparator | Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognition Assessed by RBANS
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800.
Measured: Baseline, 12, 24, and 52 Weeks
Secondary outcomes (4)
Change in Disability Function Assessed With WHODAS-II
The 12-item WHODAS-II (World Health Organization Disability Assessment Schedule) assesses functional impairment across six domains of daily living. Each item is scored on a 5-point Likert scale ranging from 0 (No difficulty), 1 (Mild Difficulty), 2 (Moderate Difficulty), 3 (Severe Difficulty) and 4 (Extreme difficulty or cannot do). Each individual item has a minimum score of 0 and a maximum of 4. The total raw score is computed by summing all 12 items, resulting in a possible score range of 0 to 48. Higher score reflect greater functional impairment. Lower scores indicate better functional status and less reported difficulty with daily activities.
Measured: Baseline, 6, 12, 24, 36, and 52 Weeks
Change in Depression Assessed by MADRS
Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score. The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.
Measured: Baseline, 6, 12, 24, 36, and 52 Weeks
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
The Delayed Recall subscale of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assesses memory function across multiple tasks. It includes the following components: List Recall Total Score (range: 0-10), List Recognition Total Score (range: 0-20), Story Recall Total Score (range: 0-12), and Figure Recall Total Score (range: 0-20). The raw scores from these four components are summed to yield a Delayed Memory Index raw total score ranging from 0 to 62, with higher scores indicating better memory performance.
To facilitate standardized interpretation, raw total scores are converted to age-adjusted Index Scores using normative data provided in the RBANS manual. These Index Scores have a mean of 100 and a standard deviation of 15, and are normed by decade (e.g., 60-69, 70-79, 80-89). Higher Index Scores reflect better memory functioning relative to age-matched peers.
Measured: Baseline, 12, 24, and 52 Weeks
Change in Executive Function Assessed by Trail Making Test
Trail Making Test is a neuropsychological assessment where raw scores are converted into a scaled score range from 1 to 25. Participants with scores between 1 - 8 have impaired performance; Mid range scores typically fall between 10 - 16, and subjects who fair the best on this measure have scores ranging from 20 - 25.
Measured: Baseline, 12, 24, and 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Jul 2017
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Montefiore Medical Center, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dimitris Kiosses, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043573
- Sponsor's protocol ID
- 1603017114
- Other IDs
- 1R01AG050514
- Acronym
- PATH-MCI
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2017
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available as per NIH's data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
- ClinicalTrials.gov ID
- NCT03043573
- Acronym / sponsor ID
- PATH-MCI / 1603017114
- Conditions
- Cognitive Impairment, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Montefiore Medical Center, National Institute on Aging (NIA)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.
Detailed description
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. Supportive Therapy incorporates standard of care approaches by using non-specific techniques to provide a supportive environment and help patients to express their feelings \& focus on their strengths and abilities.
The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40 at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited. Both sites have shown feasibility of recruitment, randomization, retention, and assessment procedures for patients with MCI. Cornell has shown evidence of administration of PATH in this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15 in-office sessions in six months.
The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses and participant randomization status, will perform research assessments at baseline and at 6 (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.
There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the blood draws is to better understand whether response to psychotherapy treatment is affected by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents) and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry) will evaluate randomly selected sessions and rate the therapists' adherence and competence based on the PATH-MCI and ST Adherence Scales
The study partner will provide information about the treatment subject and participate in treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study partner, the investigators will collect the following data from the study partner: demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client Satisfaction Questionnaire).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH-MCI | Experimental | Behavioral: PATH-MCIProblem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. |
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapySupportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Amnestic MCI as defined by Albert et al
- Montgomery Asberg Depression Rating Scale (MADRS) greater than 7 and MADRS total less than 30
- Participants will be off antidepressants, cholinesterase inhibitors or memantine, or on a stable dosage for at least 12 weeks without any medical recommendation to adjust dosage in next 3 months (during treatment)
- Clinical Dementia Rating (CDR) = 0.5 at screening
- Subjects will have capacity to consent
Key exclusion criteria (5 listed)
- Deemed to have a significant suicide risk as assessed by site PI and clinical team
- Deemed too unstable medically or neurologically to safely enroll in a research trial
- Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy. Requiring psychiatric hospitalization at baseline for safety.
- Current involvement in psychotherapy
- Lack of English fluency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH-MCIProblem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. | Behavioural | PATH-MCI |
| Supportive TherapyAlso: STST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. | Behavioural | Supportive Therapy |
Primary outcome
Change in Global Cognition Assessed by RBANS
Time frame: Baseline, 12, 24, and 52 Weeks
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800.
4 secondary outcomes
Change in Disability Function Assessed With WHODAS-II
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Change in Depression Assessed by MADRS
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS
Time frame: Baseline, 12, 24, and 52 Weeks
Change in Executive Function Assessed by Trail Making Test
Time frame: Baseline, 12, 24, and 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be available as per NIH's data sharing policy.
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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.
Dimitris Kiosses, PhD principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH-MCI and Supportive Therapy in people with Cognitive Impairment and Depression, run by Weill Medical College of Cornell University at 4 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 5 inclusion and 5 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Global Cognition Assessed by RBANS (time frame: Baseline, 12, 24, and 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.