NCT00174525

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2005

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

First QC Date

September 9, 2005

Last Update Submit

May 8, 2012

Conditions

Alzheimer's Disease

Keywords

Alzheimer's CaregiversAlzheimer disease

Outcome Measures

Primary Outcomes (1)

  • Safety assessments

Secondary Outcomes (2)

  • Blood levels of administered study drug

  • Cognitive and functional assessments

Interventions

AAB-001DRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Northridge, California, 91324-4625, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Daniel E. Grosz, MD

    Pharmacology Research Institute, Northridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2008

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(2)