Amylyx Pharmaceuticals Inc.
The proposed study will be a 24-week, randomized, double-blind, multi-site, placebo-controlled study in volunteers with late mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
Alzheimer Disease
AMX0035
Placebo
PHASE2
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in volunteers with late mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD). The study is designed to evaluate the safety, tolerability, drug target engagement and neurobiological effects of treatment with AMX0035 over 24 weeks. The study is designed to yield deep phenotyping insight for the purposes of demonstrating the effects of AMX0035 on mechanistic targets of engagement and disease biology. The study will evaluate diverse disease-relevant markers and produce an informative dataset that will allow for evaluation and correlation of imaging-based markers, neurobiological changes, functional measures, and cognitive outcomes.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 95 participants |
Masking : | QUADRUPLE |
Primary Purpose : | TREATMENT |
Official Title : | Phase II Study to Assess the Safety, Tolerability, and Target Engagement of AMX0035, a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimer's Disease |
Actual Study Start Date : | 2018-08-27 |
Estimated Primary Completion Date : | 2021-04-15 |
Estimated Study Completion Date : | 2021-08-15 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 55 Years to 89 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
CNS Healthcare - Jacksonville
Jacksonville, Florida, United States, 32256
Not yet recruiting
CNS Healthcare - Orlando
Orlando, Florida, United States, 32801
Not yet recruiting
International Medical Investigational Centers (IMIC)
Palmetto Bay, Florida, United States, 33157
Not yet recruiting
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not yet recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not yet recruiting
Rowan University
Stratford, New Jersey, United States, 08084
Not yet recruiting
Mount Sinai Alzheimer's Disease Research Center
New York, New York, United States, 10029
Not yet recruiting
Columbia University
New York, New York, United States, 10032
Not yet recruiting
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
Not yet recruiting
Center for Biomedical Research
Knoxville, Tennessee, United States, 37909