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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Biological: ACC-001(3µg) + QS21; Biological: ACC-001(10µg) + QS21; Biological: ACC-001(30µg) + QS21

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux Cedex, France, 33076
    • CMRR Bordeaux CHU Pellegrin
  • Lille, France, 59037
    • Hopital Roger Salengro
  • Marseille cedex 5, France, 13385
    • CHU la Timone
  • Paris, France, 75013
    • Groupe Hospitalier Broca-La Rochefoucauld
  • Paris, France, 75651 Cedex 13
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris Cedex 13, France, 75651
    • Hopital Pitie-Salpetriere
  • Toulouse cedex 9, France, 31059
    • Hôpital La Grave
• Germany
  • Berlin, Germany, 14050
    • Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
  • Bonn, Germany, 48129
    • Universitatsklinikum und Poliklinik der Uni Bonn
  • Freiburg, Germany, 79106
    • Klinikum der Albert-Ludwigs-Universitaet Freiburg
  • Goettingen, Germany, 37075
    • Klinik fuer Psychiatrie und Psychotherapie
  • Mannheim, Germany, 68072
    • Zentralinstitut fuer Seelische Gesundheit Mannheim
  • Munich, Germany, 81675
    • Technische Universität München
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinico Y Provincial

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACC-001(3µg) + QS21	Biological: ACC-001(3µg) + QS21; Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Experimental: ACC-001(10µg) + QS21	Biological: ACC-001(10µg) + QS21; Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Experimental: ACC-001(30µg) + QS21	Biological: ACC-001(30µg) + QS21; Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	IGM was not statistically analyzed.	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
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)	IgG subtypes were not assessed	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
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	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.	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2009
• Primary Completion (Actual): December 17, 2013
• Study Completion (Actual): December 17, 2013

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 7, 2009
• First Posted (Estimate): August 10, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Saponin QA-21V1
• Other Study ID Numbers: 3134K1-2203; B2571007 (Other Identifier: Alias Study Number); 2009-010922-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.