NCT05642429

Study of AV-1959D, an Amyloid Beta Vaccine

A Phase I, Randomized, Double-Blind Study to Evaluate Safety and Tolerability of Amyloid-β Vaccine, AV-1959D, in Patients With Early Alzheimer's Disease.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Institute for Molecular Medicine · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).

Detailed description

The Phase I study is a randomized, multicenter, double-blind, placebo-controlled study consisting of 3 sequential cohorts to determine the safety and tolerability of AV-1959D at three doses compared to a placebo in patients with early AD

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	AV-1959D	Three doses of AV-1959D administered as a sterile suspension via intradermal injection
BIOLOGICAL	Placebo	Three doses of Placebo administered as a sterile suspension via intradermal injection

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-07-20
• Completion: 2026-11-07
• First posted: 2022-12-08
• Last updated: 2026-03-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study