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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACC-001 3 μg/ QS-21 50 μg

Group Type EXPERIMENTAL

ACC-001 3 μg/ QS-21 50 μg

Intervention Type BIOLOGICAL

ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

ACC-001 10 μg/ QS-21 50 μg

Group Type EXPERIMENTAL

ACC-001 10 μg/ QS-21 50 μg

Intervention Type BIOLOGICAL

ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Placebo- Phosphate buffered saline (PBS)

Group Type PLACEBO_COMPARATOR

Placebo- Phosphate buffered saline (PBS)

Intervention Type OTHER

Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

Interventions

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ACC-001 3 μg/ QS-21 50 μg

ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Intervention Type BIOLOGICAL

ACC-001 10 μg/ QS-21 50 μg

ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Intervention Type BIOLOGICAL

Placebo- Phosphate buffered saline (PBS)

Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

Intervention Type OTHER

Other Intervention Names

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Vanutide Cridificar Vanutide Cridificar

Eligibility Criteria

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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.

Exclusion Criteria

* Significant neurological disease other than early Alzheimer's disease
* Major psychiatric disorder or symptom
* Contraindication to undergo brain MRI
* Unstable medical conditions

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Site Status

Banner Boswell Medical Center

Sun City, Arizona, United States

Site Status

Banner Lakes Imaging Center

Sun City, Arizona, United States

Site Status