NCT06223360

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Alzheimer's Disease Cooperative Study (ADCS) · Academic / Other
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled 18-month clinical trial of benfotiamine in early AD. This trial will include a seamless phase 2A-2B design with a randomized total sample of 406 participants. Participants who are randomized but drop out prior to study drug exposure will be replaced. Phase 2A of the trial will randomize approximately 150 participants total, in a 1:1:1 to treatment with 1200 mg/day benfotiamine, 600 mg/day benfotiamine or placebo. The primary objective of phase 2A is to determine the highest safe and well tolerated dose of benfotiamine (600 mg or 1200 mg), as evaluated by the rate of tolerability events (TEs), for advancement to long-term 72 week exposure. The highest tolerated dose of benfotiamine will be carried forward from phase 2A to phase 2B. At the start of phase 2B, all participants enrolled in the two phase 2A active dose arms will receive a new supply of benfotiamine at the selected phase 2B dose. All phase 2A participants will be included in the phase 2 intent-to-treat efficacy population, as assigned to active or placebo treatment. The primary objective of phase 2B is to assess efficacy of benfotiamine on global function and cognition over 72 weeks. In phase 2B, a composite cognitive and functional measure as well as PD biomarkers will be used to evaluate efficacy during the extended treatment period. Phase 2B will also evaluate longer-term safety and tolerability of benfotiamine treatment over 72 weeks.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Low Dose Benfotiamine	300mg benfotiamine capsules (BID, twice a day)
DRUG	High Dose Benfotiamine	600mg benfotiamine capsules (BID, twice a day)
DRUG	Placebo	Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Timeline

• Start date: 2024-03-28
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-01-25
• Last updated: 2026-02-23

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study