Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: ACC-001 10 μg/ QS-21 50 μg; Other: Placebo- Phosphate buffered saline (PBS); Biological: ACC-001 3 μg/ QS-21 50 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227564

B2571010

3134K1-2208 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

ACC-001 3 μg/ QS-21 50 μg

Experimental group

Treatment:

Biological: ACC-001 3 μg/ QS-21 50 μg

ACC-001 10 μg/ QS-21 50 μg

Experimental group

Treatment:

Biological: ACC-001 10 μg/ QS-21 50 μg

Placebo- Phosphate buffered saline (PBS)

Placebo Comparator group

Treatment:

Other: Placebo- Phosphate buffered saline (PBS)