Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-09-30

Brief Summary

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A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.

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Detailed Description

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The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AN-1792 also known as AIP-001

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No