Actively Recruiting
Phase 1 Study of Intrathecal ALN-5288 to Assess Safety and Effects in Adults with Alzheimers Disease Aged 40 to 80
Led by Alnylam Pharmaceuticals · Updated on 2026-07-23
50
Participants Needed
13
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacodynamic, and pharmacokinetic effects of an investigational drug called ALN-5288, administered intrathecally, in adults with Alzheimers Disease. The study focuses on adults aged 40 to 80 who have mild cognitive impairment or dementia due to Alzheimers, confirmed by clinical findings and specific biomarker tests. This is a phase 1, randomized, placebo-controlled study with a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either ALN-5288 or a placebo during the double-blind period. After this, all participants will receive ALN-5288 during the open-label extension phase. Both ALN-5288 and placebo are given through intrathecal administration. The study is designed to assess how the drug behaves in the body and its effects over time. During the study, participants will be monitored for adverse events, and various samples will be collected to measure levels of ALN-5288 and related proteins in cerebrospinal fluid, plasma, and urine. The study will last up to 32 months, with ongoing safety and pharmacokinetic assessments. This long-term monitoring includes evaluating cognitive status and ensuring participant safety throughout the trial.
CONDITIONS
Brief Title
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
Research Team
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Clinical Trial Information Line
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Clinical Trial Information Line
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