A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD

Conditions

• Early Alzheimers Disease

Eligibility Criteria

Sex

ALL

Age

55 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• buntanetap/posiphen — DRUG
  30mg capsule by mouth once daily for 18 months
• Placebo — DRUG
  Placebo capsule by mouth once daily for 18 months

Study Details

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are: * Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13? * Does buntanetap/Posiphen improve function as measured by ADCS-iADL? * What medical issues do participants have, if any, when taking buntanetap/Posiphen? Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease. Participants will: * Take buntanetap/Posiphen or a placebo every day for 18 months * Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18 * Complete pre- and post-clinic visit phone calls

Key Dates

Start date

Feb 4, 2025

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

760 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: buntanetap
• Placebo Comparator: Placebo

Primary Outcome Measure

Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) [ Time Frame: From screening to 6-month readout, to end of treatment at 18 months. ]

Locations (78)

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