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NCT06223360 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
A Phase 2 study of Alzheimer Disease, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT06223360: Recruiting Phase 2 study of Alzheimer Disease, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
NCT06223360 is a Phase 2 study of Alzheimer Disease that is actively recruiting participants, run by Alzheimer's Disease Cooperative Study (ADCS). The registered enrollment target is 406 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223360, a Phase 2 study of Alzheimer Disease, is actively recruiting participants, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.
Primary Outcome
The primary safety outcome in phase 2A is the rate of tolerability events (TEs) compared between active arms (benfotiamine) and placebo arms, at each dose. A TE is counted when either a participant discontinues study drug due to intolerability or experiences a moderate or severe adverse event (AE) that is determined to be possibly, probably or definitely related to study drug.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low Dose Benfotiamine
- DRUG High Dose Benfotiamine
Study Locations (20)
Florida
- JEM Research Institute - Atlantis
- Brain Matters Research - Delray Beach
- Neuropsychiatric Research Center of Southwest Florida - Fort Myers
- CCM Clinical Research Group, LLC - Miami
- Gonzalez MD & Aswad MD Health Services - Miami
- Miami Jewish Health - Miami
- Blue Medical Research Inc. - Miami
- Brainstorm Research - Miami
- Brain Matters Research (Kane Center) - Stuart
- Conquest Research - Winter Park
California
- The Neuron Clinic - Chula Vista
- University of California, Irvine - Irvine
- Pacific Research Network - Lemon Grove
- University of Southern California - Los Angeles
- Cedars Sinai, Los Angeles - Los Angeles
- Syrentis Clinical Research - Santa Ana
Arizona
- St. Joseph's Hospital and Medical Center/Barrow Neurological Institute - Phoenix
- Perseverance Research Center, LLC - Scottsdale
- Banner Sun Health Research Institute - Sun City
Georgia
- Emory University Goizueta Alzheimer's Disease Research Center(GADRC) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What NCT06223360 shows while recruiting
NCT06223360 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06223360 names 20 study sites across 4 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06223360 about?
NCT06223360 is a clinical study titled "A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)". The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.
What is the current status of trial NCT06223360?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 406 participants. The study started on 2024-03-28. Estimated completion is 2027-12-01.
What conditions does trial NCT06223360 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06223360?
The interventions under investigation include: Placebo (DRUG), Low Dose Benfotiamine (DRUG), High Dose Benfotiamine (DRUG).
Who is sponsoring clinical trial NCT06223360?
This trial is sponsored by Alzheimer's Disease Cooperative Study (ADCS), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06223360 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia. 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 NCT06223360's enrollment target sits among peer trials
406 62nd of 306 higher than 244 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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