Phase 2
N=63
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01227564 ↗Enrolled (actual)
63
Serious AEs
20.6%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs) — 0.009; 0.017; 0.013; 0.011 ratio — p=0.9538
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACC-001 3 μg/ QS-21 50 μg (Biological); ACC-001 10 μg/ QS-21 50 μg (Biological); Placebo- Phosphate buffered saline (PBS) (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs) |
0.009; 0.017; 0.013; 0.011; -0.011; -0.022 | 0.9538 |
Summary
This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.
Eligibility Criteria
Inclusion Criteria
- Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
- Mini-Mental State Examination (MMSE) score ≥ 25
- Global Clinical Dementia Rating = 0.5.
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
- Amyloid burden detected on screening brain PET scan.
- Other inclusion criteria apply.
Exclusion Criteria
- Significant neurological disease other than early Alzheimer's disease
- Major psychiatric disorder or symptom
- Contraindication to undergo brain MRI
- Unstable medical conditions
- Other exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01227564). 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.