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NCT01374438 · ClinicalTrials.gov registry record · Phase 2
3-month Study of MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Subjects With Alzheimer's Disease
A Phase 2 study, sponsored by Metabolic Solutions Development Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01374438: Completed Phase 2 study, sponsored by Metabolic Solutions Development Company.
NCT01374438 is a Phase 2 study that has completed, run by Metabolic Solutions Development Company. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01374438, a Phase 2 study, has completed, sponsored by Metabolic Solutions Development Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this population will also be studied. These results will be used to design larger studies of MSDC-0160 in persons with mild Alzheimer's disease.
Primary Outcome
Investigate the effect of 150 mg daily MSDC-0160 vs placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis referenced to cerebellum, including five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex. Results are reported as Standardized Uptake Value Ratios. A change from baseline in the metabolic rate of glucose that is ≥0 in
Interventions
- DRUG Placebo
- DRUG MSDC-0160
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01374438 record still lists
NCT01374438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01374438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01374438 about?
NCT01374438 is a clinical study titled "3-month Study of MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Subjects With Alzheimer's Disease". This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this population will also be s...
What is the current status of trial NCT01374438?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2011-07. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01374438?
The interventions under investigation include: Placebo (DRUG), MSDC-0160 (DRUG).
Who is sponsoring clinical trial NCT01374438?
This trial is sponsored by Metabolic Solutions Development Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01374438's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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