Study Evaluating ACC-001 in Mild to Moderate Alzheimers Disease Subjects - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00498602

Purpose

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer Disease	Drug: arm 1-ACC-001 + QS-21-Active Drug: ACC-001 Drug: QS-21-Placebo Drug: Phosphate Buffered Saline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Multicenter, Randomized, Third-Party Unblinded, Multiple Ascending Dose, Safety, Tolerability, and Immunogenicity Trial of ACC-001 in Subjects 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: QS 21

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Adverse Events and Tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cognitive and functional measures. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: ACC-001 + QS-21-Active	Drug: arm 1-ACC-001 + QS-21-Active IM injection, dose 3-30 micrograms, frequency: Day 1, month 1, 3, 6, &12.
2: Experimental Arm 2: ACC-001-Active	Drug: ACC-001 M injection, dose 3-30 micrograms, frequency: Day 1, month 1, 3, 6, &12.
3: Placebo Comparator Arm 3: QS-21	Drug: QS-21-Placebo Drug like the active
4: Placebo Comparator Drug: Phosphate Buffered Saline	Drug: Phosphate Buffered Saline

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of mild to moderate Alzheimer`s disease
Age 50-85
Mini Mental State Examination (MMSE) 16-26 Other 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: NCT00498602

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Arizona
	Recruiting
Sun City, Arizona, United States, 85351
	Recruiting
Phoenix, Arizona, United States, 85006
United States, California
	Recruiting
San Francisco, California, United States, 94143
United States, Connecticut
	Recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
	Recruiting
Washington DC, District of Columbia, United States, 20057
United States, Florida
	Recruiting
West Palm Beach, Florida, United States, 33407
	Recruiting
Hallendale, Florida, United States, 33009
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
	Recruiting
St. Louis, Missouri, United States, 63108
United States, New Jersey
	Recruiting
Long Branch, New Jersey, United States, 07740
United States, New York
	Recruiting
New York City, New York, United States, 10032
United States, Rhode Island
	Recruiting
Providence, Rhode Island, United States, 02906
United States, Vermont
	Recruiting
Bennington, Vermont, United States, 05201

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:	3134K1-2201
Study First Received:	July 9, 2007
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00498602 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Immunologic Factors
Alzheimer Disease
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Central Nervous System Diseases
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies
QS 21

ClinicalTrials.gov processed this record on February 08, 2010