Integrative Clinical Trials, LLC | Brooklyn, NY
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This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
Full description
The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Age 55 to 85 years
Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
Reliable and capable support person/caregiver
Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI] treatment), defined as:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
554 participants in 2 patient groups, including a placebo group
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Central trial contact
Hans Moebius, MD, PhD
Data sourced from clinicaltrials.gov
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