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NCT02292238 · ClinicalTrials.gov registry record · Phase 2
Benfotiamine in Alzheimer's Disease: A Pilot Study
A Phase 2 study, sponsored by Burke Medical Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT02292238 is a Phase 2 study that has completed, run by Burke Medical Research Institute. The registered enrollment target is 71 participants.
The verdict
NCT02292238, a Phase 2 study, has completed, sponsored by Burke Medical Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
General Investigational Plan Study Objectives The goal of this proposal is to determine whether enhancing brain glucose utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-blind, placebo controlled pilot study to determine if increasing brain thiamine availability with the investigational new drug benfotiamine, will minimize the decline in glucose utilization and slow the cognitive decline associated with the progression AMCI/AD dementia. Specifically, our objectives are two-fold: * To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG). * To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate. We will also carry out the following secondary objectives: * Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL, CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive domains (ie: activities of daily living, learning and memory verbal memory, behavioral, etc.) are driving these changes. * Compare ADAS-COG change scores in the benfotiamine and placebo groups within and between strata that were defined by initial cognitive impairment, to attempt to identified the population that most benefits from benfotiamine. * Compare changes in glucose utilization between the benfotiamine and placebo groups in secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and entorhinal cortex. * Compare changes in whole brain gluco
Interventions
- DRUG Benfotiamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-02-15 |
| Est. Completion | 2020-09-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02292238
The ClinicalTrials.gov registry entry for NCT02292238 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Burke Medical Research Institute, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Benfotiamine is the first listed.
NCT02292238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02292238 about?
NCT02292238 is a clinical study titled "Benfotiamine in Alzheimer's Disease: A Pilot Study". General Investigational Plan Study Objectives The goal of this proposal is to determine whether enhancing brain glucose utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-...
What is the current status of trial NCT02292238?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-02-15. Estimated completion is 2020-09-08.
What interventions are being tested in trial NCT02292238?
The interventions under investigation include: Benfotiamine (DRUG).
Who is sponsoring clinical trial NCT02292238?
This trial is sponsored by Burke Medical Research Institute, which has 11 total clinical trials registered on ClinicalTrials.gov.
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