Phase 2
N=245
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT00479557 ↗Enrolled (actual)
245
Serious AEs
17.2%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) — 97.2; 93.3; 90.0; 91.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACC-001 + QS-21 (Biological); ACC-001 (Biological); QS-21 (Biological); Placebo: Phosphate buffered saline (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) |
97.2; 93.3; 90.0; 91.4; 83.3; 90.9 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 |
50.0; 50.0; 50.0; 50.0; 50.0; 53.1 | — |
| SECONDARY GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 |
32.3; 38.2; 34.2; 32.9; 40.3; 30.8 | — |
| SECONDARY Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) |
— | — |
Summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
- Brain MRI consistent with Alzheimer Disease
- Concurent use of Chloniesterase inhibitor or memantine allowed if stable
- Other inclusion criteria apply
Exclusion Criteria
- Significant Neurological Disease other than Alzheimer's disease
- Major psychiatric disorder
- Contraindication to undergo brain MRI
- Clinically significant systemic illness
- Other exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT00479557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.