Phase 2 N=245 Randomized Quadruple-blind Treatment

Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT00498602 ↗

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); QS-21 (Biological); Diluent: Phosphate Buffered Saline (Other); ACC-001 (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Feb 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 access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.

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.

View full record on ClinicalTrials.gov →

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.