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NCT01950221 · ClinicalTrials.gov registry record · Phase 2
Pomegranate Extract and Memory
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 212
- Enrollment target
NCT01950221 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 212 participants.
The verdict
NCT01950221, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 212 participants
- Enrollment target
Study Summary
This project is designed to study whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate extract supplement. Both the placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain blindness. Subjects will take one 1000 milligram capsule daily for twelve months. The investigators expect the people receiving the pomegranate extract supplement to show better cognitive performance compared with those receiving a placebo after one, six, and twelve months. The investigators believe cognitive decline and treatment response will vary according to a genetic risk for Alzheimer's. The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo the first memory (or neuropsychological) assessments. Following the first assessment, subjects will begin taking the supplement (either the pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month mark. At six months, subjects will have a second, full neuropsychological assessment. The final assessment will take place at the end of the study, the 12-month mark. Additional blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if outcomes are positive. Subjects will also be asked to come to the University of California, Los Angeles (UCLA) at 3 and 9 months for supplement refills. In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13 months.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT POMx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01950221
The ClinicalTrials.gov registry entry for NCT01950221 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01950221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01950221 about?
NCT01950221 is a clinical study titled "Pomegranate Extract and Memory". This project is designed to study whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate extract supplement. Both the placebo and pomegranate ext...
What is the current status of trial NCT01950221?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2011-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01950221?
The interventions under investigation include: Placebo (OTHER), POMx (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01950221?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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