AgingI-CONECTNCT02871921
Internet-based Conversational Engagement Clinical Trial
A study testing Conversational Engagement in people with Aging and Mild Cognitive Impairment, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive Impairment
- What is being tested?
- Conversational Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 31 Aug 2021
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 75 or older
- Consent to MRI (if physically able to receive one)
- Socially isolated, defined by at least one of the following:
- Score ≤12 on the 6-item Lubben Social Network Scale (LSNS-6), ii. Engages in conversations lasting 30 minutes or longer no more than twice per week, per subject self-report iii. Answers "Often" to at least one question on the Hughes et al. Three-Item Loneliness Scale
- Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria:
- See well enough to complete the MoCA ii. See well enough to read a newspaper, wearing glasses if needed but not using a magnifying glass
Show all 10Show fewer
- Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as i. Able to hear well enough to complete the telephone screening ii. Able to hear well enough to complete the MoCA
- Sufficient ability to understand English in order to complete protocol-required testing
- Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist
- Sufficiently able to comply with protocol assessments and procedures, in the opinion of the investigator
Who cannot join
- Identified as having dementia based on either of the following criteria:
- Self-reported diseases associated with dementia, such as Alzheimer's disease, vascular dementia, Lewy body dementia, front temporal dementia, normal pressure hydrocephalus, or Parkinson's disease ii. Diagnosis of dementia by trial neuropsychologist
- Anticipating major change in living arrangement within the upcoming year
- Severely depressed, operationally defined as a 15-item GDS score > 7
- Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report
- Current (within 2 years of screening) alcohol or substance abuse
Show all 14Show fewer
- Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder
- Unstable or significantly symptomatic cardiovascular disease, such as coronary artery disease with frequent angina, or congestive heart failure with shortness of breath at rest
- Unstable insulin-dependent diabetes mellitus, defined as meeting any of the following criteria:
- Received a diagnosis of Type 1 Diabetes ii. Started taking insulin within 3 months of the screening visit iii. Been hospitalized for hypoglycemia within one year of screening
- Active systemic cancer within 5 years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable)
- Surgery that required full sedation with intubation within 6 months of screening (sedation for minor procedures is acceptable)
- More than one overnight hospital stay within 3 months of the screening visit
- Any other condition that, in the opinion of the investigator, is severe enough to cause study participation to have a negative impact on participant or study team rights or wellbeing.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. The participants in the Video Chat Group will receive a computer and internet service for the duration of the study, which they will use to video chat with study staff for 30 minutes/day 4x/week for 6 months (high dose), and then 2x/week for an additional 6 months (maintenance dose). The efficacy examination of the maintenance dose is limited to an exploratory aim. Both intervention and control groups will have a brief (about 10 minutes) telephone check-in with study staff once per week. In-home testing will occur at Baseline and 6 months. A sub-sample of participants** will be assessed at 12 months (exploratory) after additional 6 months of maintenance dose. All participants at OHSU will have their medication compliance tracked using an electronic medication monitoring device and participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. Participants at both sites will contribute saliva for genetic testing (optional consent), and all video chat and neuropsychological assessment sessions will be recorded for speech and language analysis (consent required for participation).
Read the detailed description
**Due to COVID-19 pandemic and resultant research hiatus and the subsequent changes in assessment modality from in-person to telephone (T-COG) assessments, M12 (Months 12) assessments are conducted only among those who completed M12 assessments before March, 18, 2020.
- Conditions
- Aging, Mild Cognitive Impairment
- Being tested
- Conversational Engagement
- Keywords
- Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic), emotional well-being
- Medical subject headings
- Cognitive Dysfunction, Social Isolation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational EngagementBehavioural
Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated
| Study group | Role | What they receive |
|---|---|---|
| Conversational Engagement | Experimental | Participants engage in 30-minute face-to-face communications with study staff through internet/webcam 4 times per week for 24 weeks (6 months). Under an exploratory aim, a limited number of participants will be further followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (6 months). Conversational staff will facilitate content-standardized but naturalistic-style social engagement. Staff and participants will engage in conversation about a wide variety of topics that are culturally and personally relevant and interesting to participants. Each day, participants will be able to choose from topic options. Participants will also receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions. Receives: Behavioral: Conversational Engagement |
| Control Group | No intervention | Participants will receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6
Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function.
Measured: Change from baseline to month 6
Secondary outcomes (3)
Intervention Efficacy for High Dose: Language-based Executive Function
Cognitive function in language-based executive function measured by Verbal Fluency Animal test. Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Higher scores indicate better cognitive function.
Measured: Change from baseline to month 6
Intervention Efficacy for High Dose: Learning Function
Cognitive function in a learning domain (immediate recall) measured by Craft Story Immediate Recall test (paraphrase scoring). Craft Story Immediate Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function. Scores reported are the mean change in score.
Measured: Change from baseline to month 6
Intervention Efficacy for High Dose: Memory Function
Cognitive function in a memory domain measured by Craft Story Delayed Recall test scores (paraphrase scoring). Craft Story Delayed Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function. Scores are reported as a change score.
Measured: Change from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start1 Jun 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Aging (NIA), Wayne State University, Oregon Health and Science University
- Responsible party
- Principal investigator, Hiroko Hayama Dodge, Massachusetts General Hospital
- Investigators
- Hiroko Dodge, PhD, Principal investigator, Oregon Health and Science Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871921
- Sponsor's protocol ID
- 2023p000367
- Other IDs
- R56AG056102, R01AG051628, R01AG056102
- Acronym
- I-CONECT
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2016
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified subject data will stored in a data repository at the conclusion of the research, and made available to approved investigators per a repository protocol.
Publications
Yu K, Wild K, Potempa K, Hampstead BM, Lichtenberg PA, Struble LM, Pruitt P, Alfaro EL, Lindsley J, MacDonald M, Kaye JA, Silbert LC, Dodge HH. The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications. Front Digit Health. 2021 Aug 25;3:714813. doi: 10.3389/fdgth.2021.714813. eCollection 2021.
PubMed 34713183Tang F, Chen J, Dodge HH, Zhou J. The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment. Front Digit Health. 2022 Feb 11;3:702772. doi: 10.3389/fdgth.2021.702772. eCollection 2021.
PubMed 35224534Liu G, Xue Z, Zhan L, Dodge HH, Zhou J. Detection of Mild Cognitive Impairment from Language Markers with Crossmodal Augmentation. Pac Symp Biocomput. 2023;28:7-18.
PubMed 36540960Chen L, Dodge HH, Asgari M. Topic-Based Measures of Conversation for Detecting Mild Cognitive Impairment. Proc Conf Assoc Comput Linguist Meet. 2020 Jul;2020:63-67.
PubMed 33642674Wu CY, Mattek N, Wild K, Miller LM, Kaye JA, Silbert LC, Dodge HH. Can changes in social contact (frequency and mode) mitigate low mood before and during the COVID-19 pandemic? The I-CONECT project. J Am Geriatr Soc. 2022 Mar;70(3):669-676. doi: 10.1111/jgs.17607. Epub 2021 Dec 13.
PubMed 34881436Yu K, Wild K, Dowling NM, Kaye JA, Silbert LC, Dodge HH. Emotional characteristics of socially isolated older adults with MCI using tablet administered NIH toolbox: I-CONECT study. Alzheimers Dement (Amst). 2022 Nov 11;14(1):e12372. doi: 10.1002/dad2.12372. eCollection 2022.
PubMed 36381558Dodge HH, Yu K, Wu CY, Pruitt PJ, Asgari M, Kaye JA, Hampstead BM, Struble L, Potempa K, Lichtenberg P, Croff R, Albin RL, Silbert LC; I-CONECT Team. Internet-Based Conversational Engagement Randomized Controlled Clinical Trial (I-CONECT) Among Socially Isolated Adults 75+ Years Old With Normal Cognition or Mild Cognitive Impairment: Topline Results. Gerontologist. 2024 Apr 1;64(4):gnad147. doi: 10.1093/geront/gnad147.
PubMed 37935416Chen L, Wu CY, Dodge HH. Changes in conversational pattern as a clinical trial outcome: a proof-of-concept study using the I-CONECT data. Innov Aging. 2026 Apr 29;10(8):igag041. doi: 10.1093/geroni/igag041. eCollection 2026.
PubMed 42404857Wu CY, Chen L, Dickson JR, Zhang B, Arnold SE, Dodge HH. Synthetic control methods for n-of-1 and parallel-group trials in Alzheimer's disease: A proof-of-concept study using the I-CONECT. Alzheimers Dement. 2025 Jul;21(7):e70460. doi: 10.1002/alz.70460.
PubMed 40621876Yuan F, Zhou W, Dodge HH, Zhao X. Short: Causal structural learning of conversational engagement for socially isolated older adults. Smart Health (Amst). 2023 Jun;28:100384. doi: 10.1016/j.smhl.2023.100384. Epub 2023 Mar 21.
PubMed 37065441
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Conversational Engagement Clinical Trial
- ClinicalTrials.gov ID
- NCT02871921
- Acronym / sponsor ID
- I-CONECT / 2023p000367
- Conditions
- Aging, Mild Cognitive Impairment
- Keywords
- Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Aging (NIA), Wayne State University, Oregon Health and Science University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. The participants in the Video Chat Group will receive a computer and internet service for the duration of the study, which they will use to video chat with study staff for 30 minutes/day 4x/week for 6 months (high dose), and then 2x/week for an additional 6 months (maintenance dose). The efficacy examination of the maintenance dose is limited to an exploratory aim. Both intervention and control groups will have a brief (about 10 minutes) telephone check-in with study staff once per week. In-home testing will occur at Baseline and 6 months. A sub-sample of participants** will be assessed at 12 months (exploratory) after additional 6 months of maintenance dose. All participants at OHSU will have their medication compliance tracked using an electronic medication monitoring device and participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. Participants at both sites will contribute saliva for genetic testing (optional consent), and all video chat and neuropsychological assessment sessions will be recorded for speech and language analysis (consent required for participation).
Detailed description
**Due to COVID-19 pandemic and resultant research hiatus and the subsequent changes in assessment modality from in-person to telephone (T-COG) assessments, M12 (Months 12) assessments are conducted only among those who completed M12 assessments before March, 18, 2020.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational Engagement | Experimental | Behavioral: Conversational EngagementParticipants engage in 30-minute face-to-face communications with study staff through internet/webcam 4 times per week for 24 weeks (6 months). Under an exploratory aim, a limited number of participants will be further followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (6 months). Conversational staff will facilitate content-standardized but naturalistic-style social engagement. Staff and participants will engage in conversation about a wide variety of topics that are culturally and personally relevant and interesting to participants. Each day, participants will be able to choose from topic options. Participants will also receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions. |
| Control Group | No intervention | –Participants will receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age 75 or older
- Consent to MRI (if physically able to receive one)
- Socially isolated, defined by at least one of the following:
- Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria:
- Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as i. Able to hear well enough to complete the telephone screening ii. Able to hear well enough to complete the MoCA
Key exclusion criteria (14 listed)
- Identified as having dementia based on either of the following criteria:
- Anticipating major change in living arrangement within the upcoming year
- Severely depressed, operationally defined as a 15-item GDS score > 7
- Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report
- Current (within 2 years of screening) alcohol or substance abuse
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 |
|---|---|---|
| Conversational EngagementExamine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated | Behavioural | Conversational Engagement |
Primary outcome
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6
Time frame: Change from baseline to month 6
Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function.
3 secondary outcomes
Intervention Efficacy for High Dose: Language-based Executive Function
Time frame: Change from baseline to month 6
Intervention Efficacy for High Dose: Learning Function
Time frame: Change from baseline to month 6
Intervention Efficacy for High Dose: Memory Function
Time frame: Change from baseline to month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34713183Yu K, Wild K, Potempa K, Hampstead BM, Lichtenberg PA, Struble LM, Pruitt P, Alfaro EL, Lindsley J, MacDonald M, Kaye JA, Silbert LC, Dodge HH. The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications. Front Digit Health. 2021 Aug 25;3:714813. doi: 10.3389/fdgth.2021.714813. eCollection 2021.
- Background: PubMed 35224534Tang F, Chen J, Dodge HH, Zhou J. The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment. Front Digit Health. 2022 Feb 11;3:702772. doi: 10.3389/fdgth.2021.702772. eCollection 2021.
- Background: PubMed 36540960Liu G, Xue Z, Zhan L, Dodge HH, Zhou J. Detection of Mild Cognitive Impairment from Language Markers with Crossmodal Augmentation. Pac Symp Biocomput. 2023;28:7-18.
- Background: PubMed 33642674Chen L, Dodge HH, Asgari M. Topic-Based Measures of Conversation for Detecting Mild Cognitive Impairment. Proc Conf Assoc Comput Linguist Meet. 2020 Jul;2020:63-67.
- Background: PubMed 34881436Wu CY, Mattek N, Wild K, Miller LM, Kaye JA, Silbert LC, Dodge HH. Can changes in social contact (frequency and mode) mitigate low mood before and during the COVID-19 pandemic? The I-CONECT project. J Am Geriatr Soc. 2022 Mar;70(3):669-676. doi: 10.1111/jgs.17607. Epub 2021 Dec 13.
- Background: PubMed 36381558Yu K, Wild K, Dowling NM, Kaye JA, Silbert LC, Dodge HH. Emotional characteristics of socially isolated older adults with MCI using tablet administered NIH toolbox: I-CONECT study. Alzheimers Dement (Amst). 2022 Nov 11;14(1):e12372. doi: 10.1002/dad2.12372. eCollection 2022.
- Results publication: PubMed 37935416Dodge HH, Yu K, Wu CY, Pruitt PJ, Asgari M, Kaye JA, Hampstead BM, Struble L, Potempa K, Lichtenberg P, Croff R, Albin RL, Silbert LC; I-CONECT Team. Internet-Based Conversational Engagement Randomized Controlled Clinical Trial (I-CONECT) Among Socially Isolated Adults 75+ Years Old With Normal Cognition or Mild Cognitive Impairment: Topline Results. Gerontologist. 2024 Apr 1;64(4):gnad147. doi: 10.1093/geront/gnad147.
- Derived from this study: PubMed 42404857Chen L, Wu CY, Dodge HH. Changes in conversational pattern as a clinical trial outcome: a proof-of-concept study using the I-CONECT data. Innov Aging. 2026 Apr 29;10(8):igag041. doi: 10.1093/geroni/igag041. eCollection 2026.
- Derived from this study: PubMed 40621876Wu CY, Chen L, Dickson JR, Zhang B, Arnold SE, Dodge HH. Synthetic control methods for n-of-1 and parallel-group trials in Alzheimer's disease: A proof-of-concept study using the I-CONECT. Alzheimers Dement. 2025 Jul;21(7):e70460. doi: 10.1002/alz.70460.
- Derived from this study: PubMed 37065441Yuan F, Zhou W, Dodge HH, Zhao X. Short: Causal structural learning of conversational engagement for socially isolated older adults. Smart Health (Amst). 2023 Jun;28:100384. doi: 10.1016/j.smhl.2023.100384. Epub 2023 Mar 21.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified subject data will stored in a data repository at the conclusion of the research, and made available to approved investigators per a repository protocol.
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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.
Hiroko Dodge, PhD principal investigator
Oregon Health and Science Univeristy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational Engagement in people with Aging and Mild Cognitive Impairment, run by Massachusetts General Hospital 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 10 inclusion and 14 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 2 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2024). 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?
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6 (time frame: Change from baseline to month 6). 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 NCT02871921, which also lists 10 linked publications.
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 2 Apr 2024.