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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Biological: ACC-001

• Registration Number: NCT01238991
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Study Start: 2010-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-12
• Results First Submitted QC: 2014-12-12
• Last Update Submitted: 2014-12-12
• Results First Posted: 2014-12-22
• Last Update Posted: 2014-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACC-001 (30 micrograms) + QS-21	ACC-001	Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (3 micrograms) + QS-21	ACC-001	Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (10 micrograms) + QS-21	ACC-001	Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Primary Outcome Measures

Name	Time	Method
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data	Baseline up to 24 months	Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Number of Treatment Emergent Adverse Events (AEs) by Severity	Baseline up to 24 months	Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Number of Participants With Abnormalities in Neurological Examination	Baseline of the preceding studies through 24 months of this study	Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.

Trial Locations

Locations (11)

Shonan Atsugi Hospital; 🇯🇵 Atsugi, Kanagawa, Japan

Ibaraki Prefectural Central Hospital; 🇯🇵 Kasama, Ibaraki, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Meitetsu Hospital; 🇯🇵 Nagoya, Aichi, Japan

Osaka Medical College Hospital; 🇯🇵 Takatsuki, Osaka, Japan

Kitasato University East Hospital; 🇯🇵 Sagamihara-shi, Kanagawa, Japan

The Tokyo Jikei University School of Medicine; 🇯🇵 Minato-ku, Tokyo, Japan

Suwa Red Cross Hospital; 🇯🇵 Suwa, Nagano, Japan

Tazuke Kofukai Medical Research Institute Kitano Hospital; 🇯🇵 Osaka, Japan

Juntendo Tokyo Koto Geriatric Medical Center; 🇯🇵 Koto-ku, Tokyo, Japan

Kanto Central Hospital of the Mutual Aid Association of Public School Teachers; 🇯🇵 Setagaya-ku, Tokyo, Japan