Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

Conditions

• Alzheimer Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - 87 Years

Healthy Volunteers

Not accepted

Interventions

• Simufilam — DRUG
  Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
• Placebo — DRUG
  Matching placebo given b.i.d. for 52 weeks.

Study Details

A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.

Key Dates

Start date

Nov 3, 2021

Status verified

May 2025

Primary completion

Oct 2, 2024

Completion

Oct 2, 2024

Study Design

Enrollment

804 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
• Experimental: Simufilam 100 mg
  Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks

Primary Outcome Measure

Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) [ Time Frame: Baseline (Study Day 1) to Week 52 ]

Locations (74)

Find similar trials in Chandler, AZ

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