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| Sponsored by: |
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. |
| 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.
|
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2: Experimental
Arm 2: ACC-001-Active
|
Drug: ACC-001
M injection, dose 3-30 micrograms, frequency: Day 1, month 1, 3, 6, &12.
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3: Placebo Comparator
Arm 3: QS-21
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Drug: QS-21-Placebo
Drug like the active
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Trial Manager | clintrialparticipation@wyeth.com |
| 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 | |
| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3134K1-2201 |
| Study First Received: | July 9, 2007 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00498602 |
| Health Authority: | United States: Food and Drug Administration |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases QS 21 |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
|
Immunologic Factors Physiological Effects of Drugs Nervous System Diseases |
Adjuvants, Immunologic Tauopathies Pharmacologic Actions |
