Long Term Extension Study Evaluating ACC-001 in Subjects With Mild to Moderate Alzheimer's Disease - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00955409

Purpose

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer Disease	Drug: ACC-001 + QS21 Drug: ACC-001	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Long-Term Extension Study to Determine Safety, Tolerability, and Immunogenicity of ACC-001 With and Without QS-21 Adjuvant 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:

Incidence and severity of treatment emergent adverse events; clinically important changes in safety assessment results including adverse events , vital signs, weight, clinical laboratory tests, ECGs, MRI scans, and physical and neurological examinations. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline levels of anti-A-beta IgG, Anti-A-beta IgM and IgG subclass antibody levels at selected time points. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	August 2009
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 ACC-001(3µg) + QS21	Drug: ACC-001 + QS21
2 ACC-001(10µg) + QS21	Drug: ACC-001 + QS21
3 ACC-001(10µg)	Drug: ACC-001
4 ACC-001(30µg) + QS21	Drug: ACC-001 + QS21
5 ACC-001(30µg)	Drug: ACC-001

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
Screening brain MRI scan is consistent with the diagnosis of AD Mini-Mental State Examination (MMSE) score ≥ 10
Other exclusion criteria apply

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease
Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
Clinically significant systemic illness
Other exclusion criteria apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955409

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

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:	3134K1-2203
Study First Received:	August 4, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955409 History of Changes
Health Authority:	European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Spain: Ministry of Health

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Adjuvants, Immunologic
Central Nervous System Diseases
QS 21

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 11, 2009