A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecal ALN-5288 in Adults with Alzheimer’s Disease

The primary objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intrathecally administered ALN-5288 in adult patients diagnosed with Alzheimer’s disease. This assessment is critical for establishing the clinical profile and biological activity of the investigational agent in the central nervous system. The study scope encompasses 4: Safety, 5: Efficacy, 6: Pharmacokinetic, and 7: Pharmacodynamic evaluations.

This clinical trial involves a total of 35 patients diagnosed with Alzheimer’s disease. The study population includes both male and female participants. Based on the provided age range codes, the subjects fall within specific age categories. The sponsor did not provide additional information regarding lifestyle considerations or specific inclusion and exclusion criteria.

This Phase 1 clinical trial is a randomized, placebo-controlled study featuring a double-blind period followed by an open-label extension period. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intrathecally administered ALN-5288 in adult patients diagnosed with Alzheimer’s disease. The study protocol involves a screening visit to determine eligibility, followed by scheduled study visits and an end-of-study visit. The total duration of participant involvement is not specified. Study termination may occur based on predefined clinical criteria.

The assessment of efficacy in this clinical trial concerning Alzheimer’s disease is not specified.