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NCT01299766 · ClinicalTrials.gov registry record · Phase 3
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
NCT01299766: Completed Phase 3 study, sponsored by Thomas Jefferson University.
NCT01299766 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 221 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01299766, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.
Primary Outcome
A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.
Interventions
- BEHAVIORAL Supportive Therapy (ST)
- BEHAVIORAL Behavioral Activation (BA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2016-12-13 |
| Phase | Phase 3 |
What the finished NCT01299766 record still lists
NCT01299766 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Supportive Therapy (ST) is the first listed.
NCT01299766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01299766 about?
NCT01299766 is a clinical study titled "Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment". The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose ...
What is the current status of trial NCT01299766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2011-06-21. Estimated completion is 2016-12-13.
What interventions are being tested in trial NCT01299766?
The interventions under investigation include: Supportive Therapy (ST) (BEHAVIORAL), Behavioral Activation (BA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01299766?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01299766's enrollment target sits among peer trials
221 1318th of 2000 higher than 683 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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