Safety Study of Passive Immunization for Patients With Mild to Moderate 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

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-04-30

Brief Summary

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This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.

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Detailed Description

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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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AAB-001

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable AD
* Age from 50 to 85 years, inclusive
* Rosen Modified Hachinski ischemic score less than or equal to 4
* Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
* Fluency in English
* Stable doses of medications

Exclusion Criteria

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure
* Weight greater than 120kg (264 lbs.)
* History of autoimmune disease
* Smoking more than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment with experimental immunotherapeutics or vaccines for AD
* Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No