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Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease

NCT03533257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-03-07

Study results available
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Summary

The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).

Conditions

  • Alzheimer Disease

Interventions

DRUG

AMX0035

Combination Therapy of PB and TURSO

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • Alzheimer's Association

    collaborator OTHER

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Yeramian, MD · Amylyx Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2020-10-22
Completion
2020-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03533257 on ClinicalTrials.gov