Phase 2
Completed N=245
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00498602 ↗Enrolled (actual)
245
Serious AEs
17.2%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) — 97.2; 93.3; 90.0; 91.4 percentage of participants
Summary
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.
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) |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00498602). 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. Informational only — not medical advice.