NCT05363293

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

A Multiple-dose, Steady-state, Double-blind, Ascending Dose, Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Mild to Moderate Alzheimer's Disease and Healthy Adult Subjects ("MAD Study")

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Alzamend Neuro, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.

Detailed description

This is a Phase 1/2a, multi-center, placebo-controlled, double-blind, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose (MTD) of AL001, a crystal engineered lithium-salicylate-proline lithium delivery product that in nonclinical studies was shown to enhance and prolong the pharmacokinetic (PK) profile of lithium in the brain with enhanced efficacy potential in Alzheimer's models compared to lithium carbonate. A maximum of approximately 72 participants will be enrolled. Participants will be randomly assigned to receive study drug (active AL001) or placebo in a ratio of 6:2, respectively, with 8 patients in each dosing cohort. Placebos will be pooled and regarded as a comparative cohort for safety. Cohorts 2a, 3a, 4a and 5a will involve 1:1 healthy non-elderly and elderly subjects; cohorts 1, 2b, 3b, 4b and 5b will involve Alzheimer's subjects. The study will consist of a screening period (Days -28 to -2), a 14-day treatment period, and a 42-day follow-up period.

Conditions

• Alzheimer's Disease
• Healthy Non-elderly and Elderly Adults

Interventions

Type	Name	Description
DRUG	AL001	a crystal engineered lithium-salicylate-proline lithium delivery product
OTHER	Placebo	matching placebo formulation

Timeline

• Start date: 2022-05-04
• Primary completion: 2023-04-14
• Completion: 2023-05-15
• First posted: 2022-05-05
• Last updated: 2025-05-14
• Results posted: 2025-05-14

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study