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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACC-001(3µg) + QS21
ACC-001(10µg) + QS21
ACC-001(30µg) + QS21
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
  • Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
  • Clinically significant systemic illness

Sites / Locations

  • CMRR Bordeaux CHU Pellegrin
  • Hopital Roger Salengro
  • Hôpital Roger Salengro
  • CHU La Timone
  • Hôpital Pitié-Salpétrière
  • Groupe Hospitalier Broca-La Rochefoucauld
  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital La Grave
  • Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
  • Universitatsklinikum und Poliklinik der Uni Bonn
  • Klinikum der Albert-Ludwigs-Universitaet Freiburg
  • Klinik fuer Psychiatrie und Psychotherapie
  • Zentralinstitut fuer Seelische Gesundheit Mannheim
  • Technische Universität München
  • Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinico y Provincial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ACC-001(3µg) + QS21

ACC-001(10µg) + QS21

ACC-001(30µg) + QS21

Arm Description

ACC-001(3µg) + QS21

ACC-001(10µg) + QS21

ACC-001(30µg) + QS21

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2009
Last Updated
March 1, 2021
Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00955409
Brief Title
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title
A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2009 (Actual)
Primary Completion Date
December 17, 2013 (Actual)
Study Completion Date
December 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACC-001(3µg) + QS21
Arm Type
Experimental
Arm Description
ACC-001(3µg) + QS21
Arm Title
ACC-001(10µg) + QS21
Arm Type
Experimental
Arm Description
ACC-001(10µg) + QS21
Arm Title
ACC-001(30µg) + QS21
Arm Type
Experimental
Arm Description
ACC-001(30µg) + QS21
Intervention Type
Biological
Intervention Name(s)
ACC-001(3µg) + QS21
Intervention Description
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Intervention Type
Biological
Intervention Name(s)
ACC-001(10µg) + QS21
Intervention Description
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Intervention Type
Biological
Intervention Name(s)
ACC-001(30µg) + QS21
Intervention Description
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Description
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Description
IGM was not statistically analyzed.
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Title
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)
Description
IgG subtypes were not assessed
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Title
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Description
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Time Frame
Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10 Exclusion Criteria: Significant Neurological Disease other than Alzheimer's disease Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557) Clinically significant systemic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CMRR Bordeaux CHU Pellegrin
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU La Timone
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Pitié-Salpétrière
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Groupe Hospitalier Broca-La Rochefoucauld
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651 Cedex 13
Country
France
Facility Name
Hôpital La Grave
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Universitatsklinikum und Poliklinik der Uni Bonn
City
Bonn
ZIP/Postal Code
48129
Country
Germany
Facility Name
Klinikum der Albert-Ludwigs-Universitaet Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinik fuer Psychiatrie und Psychotherapie
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Zentralinstitut fuer Seelische Gesundheit Mannheim
City
Mannheim
ZIP/Postal Code
68072
Country
Germany
Facility Name
Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinico y Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-2203
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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