Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

Phase 2

Completed

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

• Registration Number: NCT00752232
• Lead Sponsor: Pfizer

Brief Summary

The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Study Start: 2008-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• 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: 40

Inclusion Criteria

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

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Exclusion Criteria

• Significant Neurological Disease
• Major Psychiatric Disorder
• Clinically significant systemic illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ACC-001+QS-21	QS-21	Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
ACC-001+QS-21	ACC-001	Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
ACC-001	ACC-001	Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
PBS	PBS	Placebo, IM injection, Day 1, month 3, 6, 9, 12
QS-21	QS-21	Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12

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

Trial Locations

Locations (10)

Kitasato University East Hospital; 🇯🇵 Kanagawa, Japan

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

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

Juntendo University Hospital; 🇯🇵 Tokyo, Japan

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

Meitetsu Hospital; 🇯🇵 Aichi, Japan

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

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

Shonan Atsugi Hospital; 🇯🇵 Kanagawa, Japan

Ibaraki Prefectural Central Hospital; 🇯🇵 Ibaraki, Japan