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Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

NCT ID: NCT01238991

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACC-001 (3 micrograms) + QS-21

Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Group Type EXPERIMENTAL

ACC-001

Intervention Type BIOLOGICAL

IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18

ACC-001 (10 micrograms) + QS-21

Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Group Type EXPERIMENTAL

ACC-001

Intervention Type BIOLOGICAL

IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18

ACC-001 (30 micrograms) + QS-21

Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Group Type EXPERIMENTAL

ACC-001

Intervention Type BIOLOGICAL

IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

Interventions

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ACC-001

IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18

Intervention Type BIOLOGICAL

ACC-001

IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18

Intervention Type BIOLOGICAL

ACC-001

IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Screening brain MRI scan is consistent with the diagnosis of AD.
* MMSE score 10 and above.

Exclusion Criteria

* Significant neurological diseases other than AD.
* Brain MRI evidence of vasogenic edema during the preceding studies.
* Clinically significant illness.
Minimum Eligible Age

52 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JANSSEN Alzheimer Immunotherapy Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

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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Meitetsu Hospital

Nagoya, Aichi-ken, Japan

Site Status

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, Japan

Site Status

Shonan Atsugi Hospital

Atsugi, Kanagawa, Japan

Site Status

Kitasato University East Hospital

Sagamihara-shi, Kanagawa, Japan

Site Status

Suwa Red Cross Hospital

Suwa, Nagano, Japan

Site Status

Tazuke Kofukai Medical Research Institute Kitano Hospital

Osaka, Osaka, Japan

Site Status

Osaka Medical College Hospital

Takatsuki, Osaka, Japan

Site Status

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

Juntendo Tokyo Koto Geriatric Medical Center

Koto-ku, Tokyo, Japan

Site Status

The Tokyo Jikei University School of Medicine

Minato-ku, Tokyo, Japan

Site Status

Kanto Central Hospital of the Mutual Aid Association of Public School Teachers

Setagaya-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2571001&StudyName=Long%20Term%20Extension%20Study%20Evaluating%20Safety%2C%20Tolerability%20And%20Immunogenicity%20Of%20ACC-001%20In%20Japanese%20Subjects%20With%20Mild%20To%20Moderate%20Alzhe

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Other Identifiers

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3134K1-2207

Identifier Type: OTHER

Identifier Source: secondary_id

B2571001

Identifier Type: -

Identifier Source: org_study_id