| Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease |
| A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease. |
| The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Alzheimer Disease |
- Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
- Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
- Other: PBS
IM injection, Day 1, month 3, 6, 9, 12
|
- Experimental: ACC-001+QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Interventions:
- Biological: ACC-001
- Other: QS-21
- Experimental: ACC-001
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Intervention: Biological: ACC-001
- Placebo Comparator: QS-21
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Intervention: Other: QS-21
- Placebo Comparator: PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
Intervention: Other: PBS
|
| Not Provided |
| |
| Completed |
| 40 |
| July 2012 |
| July 2012 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini Mental Status Exam (MMSE) of 16-26
Exclusion Criteria:
- Significant Neurological Disease
- Major Psychiatric Disorder
- Clinically significant systemic illness
|
| Sexes Eligible for Study: |
All |
|
| 50 Years to 85 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| |
| NCT00752232 |
3134K1-2202
B2571006 ( Other Identifier: Alias Study Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2015 |
