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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Other: QS-21; Biological: ACC-001

• Registration Number: NCT00959192
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2014-05-09
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-30
• Last Update Submitted: 2015-11-30
• Results First Posted: 2016-01-01
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Diagnosis of mild to moderate Alzheimer's Disease
• Mini-Mental State Examination (MMSE) 16-26

Exclusion Criteria

• Significant Neurological Disease other than Alzheimer's disease
• Major psychiatric disorder
• Clinically significant systemic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QS-21	QS-21	Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
ACC-001 + QS-21	ACC-001	Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
ACC-001 + QS-21	QS-21	Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events (AEs) by Severity	Baseline up to 24 months	Number of participants who experienced mild, moderate, or 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 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 Participants With Abnormalities in Neurological Examination	Baseline up to 24 months	Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.

Secondary Outcome Measures

Name	Time	Method
Anti-a-beta IgM Titer at Specified Visits	Baseline up to 24 months	Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Anti-a-beta IgG Titer at Specified Visits	Baseline up to 24 months	Geometric mean of anti-a-beta IgG titer from pre-study through Week 104

Trial Locations

Locations (9)

Kitasato University East Hospital; 🇯🇵 Kanagawa, Japan

Ibaraki Prefectural Central Hospital; 🇯🇵 Ibaraki, Japan

Meitetsu Hospital; 🇯🇵 Aichi, Japan

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

Shonan Atsugi Hospital; 🇯🇵 Kanagawa, Japan

The Jikei University School of medicine; 🇯🇵 Tokyo, Japan

Juntendo University Hospital; 🇯🇵 Tokyo, Japan

Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache; 🇯🇵 Tokyo, Japan

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