Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease

Summary

Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be conducted to determine the clinical efficacy of TB006 in participants with mild to severe Alzheimer's Disease.

Timeline

Start

2021-10-08

Primary completion

2022-10-13

Completion

2022-10-13

Outcome

Missed primary endpoint

registry Part 2: TB006 1000 mg qw vs Part 2: Placebo; p = 0.0838 NCT05074498 ↗

Drugs

Indications