This trial is active, not recruiting.

Condition alzheimer's disease
Treatment aab-001
Phase phase 2
Sponsor Pharmacology Research Institute
Start date April 2005
End date April 2008
Trial identifier NCT00174525, PRI#585


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Safety assessments
time frame:

Secondary Outcomes

Blood levels of administered study drug
time frame:
Cognitive and functional assessments
time frame:

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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

Additional Information

Official title A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
Principal investigator Daniel E. Grosz, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Pharmacology Research Institute.