Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00397891

Purpose

Evaluate safety, tolerability, and phamacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer Disease	Drug: bapineuzumab	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmakokinetic Study of Single Ascending Doses of AAB-001 in Japanese Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Bapineuzumab

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety and tolerability of single ascending doses of AAB-001 in Japanese subjects with mild to moderate AD. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Characterize the pharmacokinetic (PK) profile of single doses of AAB-001 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	October 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental bapineuzumab 0.15 mg/kg or placebo	Drug: bapineuzumab The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
2: Experimental bapineuzumab 0.5 mg/kg or placebo	Drug: bapineuzumab The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
3: Experimental bapineuzumab 1.0 mg/kg or placebo	Drug: bapineuzumab The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of AD
Age 50-85
MMSE 14-26
Other Inclusion Criteria Apply

Exclusion Criteria

Significant Neurological Disease
Major Psychiatric Disorder
Clinically Significant Systemic Illness
Other Exclusion Criteria Apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397891

Locations

Japan, Chiba

2-1-1, Tomioka, Urayasu-shi, Chiba, Japan, 279-0021
Japan, Saitama

Koshigaya, Saitama, Japan, 343-0032
Japan, Shizuoka

1-20-1, Handayam, Hamamatsu-shi, Shizuoka, Japan, 431-3192

Izunokuni, Shizuoka, Japan, 410-2295
Japan, Tokyo

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan, 113-8431

3-3-20, Shinsuna, Koto-ku, Tokyo, Japan, 136-0075

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3133K1-102
Study First Received:	November 8, 2006
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00397891 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 01, 2009