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NCT02221622 · ClinicalTrials.gov registry record · Phase 1
Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD
A Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02221622: Completed Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of Southern California.
NCT02221622 is a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment that has completed, run by University of Southern California. The registered enrollment target is 24 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02221622, a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. The primary goal is to determine the maximally tolerated dose.
Primary Outcome
Incidence and severity of treatment emergent adverse events assessed weekly per treatment arm.
Conditions Studied
Interventions
- DRUG Allopregnanolone injection (intravenous solution)
- DRUG Placebo injection (intravenous solution)
Study Locations (1)
California
- University of Southern California - Alzheimer Disease Research Center - Healthcare Consultation Center II - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-02 |
| Phase | Phase 1 |
What the finished NCT02221622 record still lists
NCT02221622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Allopregnanolone injection (intravenous solution) is the first listed.
NCT02221622 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02221622 about?
NCT02221622 is a clinical study titled "Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD". The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease participants. The primary goal is to determine the maximally tolerated dose.
What is the current status of trial NCT02221622?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-08. Estimated completion is 2018-02.
What conditions does trial NCT02221622 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment.
What interventions are being tested in trial NCT02221622?
The interventions under investigation include: Allopregnanolone injection (intravenous solution) (DRUG), Placebo injection (intravenous solution) (DRUG).
Who is sponsoring clinical trial NCT02221622?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02221622 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02221622's enrollment target sits among peer trials
24 258th of 306 higher than 45 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
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