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

NCT01227564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-02-25

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

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

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

OTHER

Placebo- Phosphate buffered saline (PBS)

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

Sponsors & Collaborators

  • JANSSEN Alzheimer Immunotherapy Research & Development, LLC

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227564 on ClinicalTrials.gov