PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

NCT04079803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-09-29

Study results available
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Summary

This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Placebo oral tablet

Oral placebo tablet

DRUG

Simufilam 100 mg tablet

Simufilam 100 mg oral tablet

DRUG

Simufilam 50 mg oral tablet

Simufilam 50 mg oral tablet

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsay Burns, PhD · Cassava Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079803 on ClinicalTrials.gov