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

November 30, 2015 updated by: Pfizer

A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 451-8511
        • Meitetsu Hospital
      • Ibaraki, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital
      • Kanagawa, Japan, 243-8551
        • Shonan Atsugi Hospital
      • Kanagawa, Japan, 252-0380
        • Kitasato University East Hospital
      • Osaka, Japan, 530-8480
        • Tazuke Kofukai Medical Research Institute Kitano Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
      • Tokyo, Japan, 158-8531
        • Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
    • Nagano
      • Suwa, Nagano, Japan, 392-8510
        • Suwa Red Cross Hospital
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACC-001+QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Experimental: ACC-001
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: QS-21
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
Other: PBS
IM injection, Day 1, month 3, 6, 9, 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Time Frame: 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)
Baseline up to 24 months
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time Frame: 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.
Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
Time Frame: 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.
Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-a-beta IgG Titer at Specified Visits
Time Frame: Baseline up to 24 months
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Time Frame: Baseline up to 24 months
Geometric mean of anti-a-beta IgM titer from pre-study through Week 104
Baseline up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
Time Frame: Baseline up to 24 months
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.
Baseline up to 24 months
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
Time Frame: Baseline up to 24 months
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
Baseline up to 24 months
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
Time Frame: Baseline up to 24 months
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
Baseline up to 24 months
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.
Time Frame: Baseline up to 24 months
The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
Baseline up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3134K1-2202
  • B2571006 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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