NCT00955409

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 alzheimer-disease

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_2 alzheimer-disease

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 5, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2013

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

4.1 years

First QC Date

August 4, 2009

Results QC Date

December 17, 2014

Last Update Submit

March 1, 2021

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    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)

    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

    Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Study Arms (3)

ACC-001(3µg) + QS21

EXPERIMENTAL

ACC-001(3µg) + QS21

Biological: ACC-001(3µg) + QS21

ACC-001(10µg) + QS21

EXPERIMENTAL

ACC-001(10µg) + QS21

Biological: ACC-001(10µg) + QS21

ACC-001(30µg) + QS21

EXPERIMENTAL

ACC-001(30µg) + QS21

Biological: ACC-001(30µg) + QS21

Interventions

ACC-001(3µg) + QS21BIOLOGICAL

Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

ACC-001(3µg) + QS21
ACC-001(10µg) + QS21BIOLOGICAL

Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

ACC-001(10µg) + QS21
ACC-001(30µg) + QS21BIOLOGICAL

Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

ACC-001(30µg) + QS21

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CMRR Bordeaux CHU Pellegrin

Bordeaux, 33076, France

Location

Hopital Roger Salengro

Lille, 59037, France

Location

Hôpital Roger Salengro

Lille, 59037, France

Location

CHU La Timone

Marseille, 13385, France

Location

Groupe Hospitalier Broca-La Rochefoucauld

Paris, 75013, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75651 Cedex 13, France

Location

Hôpital Pitié-Salpétrière

Paris, 75651, France

Location

Hôpital La Grave

Toulouse, 31059, France

Location

Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

Berlin, 14050, Germany

Location

Universitatsklinikum und Poliklinik der Uni Bonn

Bonn, 48129, Germany

Location

Klinikum der Albert-Ludwigs-Universitaet Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinik fuer Psychiatrie und Psychotherapie

Göttingen, 37075, Germany

Location

Zentralinstitut fuer Seelische Gesundheit Mannheim

Mannheim, 68072, Germany

Location

Technische Universität München

Munich, 81675, Germany

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinico y Provincial

Barcelona, 08036, Spain

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

vanutide cridificarsaponin QA-21V1

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

In 2013 the sponsor decided that ACC-001 would not be further developed in mild to moderate Alzheimer's disease, study drug administration was discontinued, and remaining participants were followed for safety for up to 6 months after last injection.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 10, 2009

Study Start

November 5, 2009

Primary Completion

December 17, 2013

Study Completion

December 17, 2013

Last Updated

March 25, 2021

Results First Posted

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

FR(8)DE(6)ES(3)