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

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	Phase II

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

QS 21

U.S. FDA Resources

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.

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:	228
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 3-90 micrograms, frequency: Day 1, month 1, 3, 6, &12.
2: Experimental Arm 2: ACC-001-Active	Drug: ACC-001 M injection, dose 3-90 micrograms, frequency: Day 1, month 1, 3, 6, &12.
3: Placebo Comparator Arm 3: QS-21-Placebo	Drug: QS-21-Placebo Drug like the active

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

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3134K1-2201
First Received:	July 9, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00498602
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

QS 21

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Nervous System Diseases

Adjuvants, Immunologic

Tauopathies

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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