Clinical trial NCT00955409: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2009-08-10
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
measure: 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)
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
measure: 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
timeFrame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Locations:
city: Bordeaux Cedex
country: France
facility: CMRR Bordeaux CHU Pellegrin
city: Lille
country: France
facility: Hopital Roger Salengro
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Marseille cedex 5
country: France
facility: CHU La Timone
city: Paris Cedex 13
country: France
facility: Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: Groupe Hospitalier Broca-La Rochefoucauld
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Toulouse cedex 9
country: France
facility: Hôpital La Grave
city: Berlin
country: Germany
facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
city: Bonn
country: Germany
facility: Universitatsklinikum und Poliklinik der Uni Bonn
city: Freiburg
country: Germany
facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg
city: Goettingen
country: Germany
facility: Klinik fuer Psychiatrie und Psychotherapie
city: Mannheim
country: Germany
facility: Zentralinstitut fuer Seelische Gesundheit Mannheim
city: Munich
country: Germany
facility: Technische Universität München
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: