NCT00479557

Brief Summary

To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients 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
86

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started May 2007

Longer than P75 for phase_2 alzheimer-disease

Geographic Reach
3 countries

24 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

Study Start

First participant enrolled

May 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

January 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

November 1, 2015

Enrollment Period

5.7 years

First QC Date

May 24, 2007

Results QC Date

May 6, 2014

Last Update Submit

November 30, 2015

Conditions

Alzheimer Disease

Keywords

Alzheimer's Diseaseactive immunization

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.

    approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.

Secondary Outcomes (3)

  • Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

    Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

  • GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

    Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)

    Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Study Arms (4)

1

ACTIVE COMPARATOR

arm 1: ACC-001 (Vanutide Cridificar)+ QS-21

Biological: ACC-001 + QS-21

2

ACTIVE COMPARATOR

arm 2: ACC-001

Biological: ACC-001

3

PLACEBO COMPARATOR

arm 3: QS-21

Biological: QS-21

4

PLACEBO COMPARATOR

Drug: Phosphate Buffered Saline (PBS)

Drug: Placebo: Phosphate buffered saline

Interventions

ACC-001 + QS-21BIOLOGICAL

Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

1
ACC-001BIOLOGICAL

Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12

2
QS-21BIOLOGICAL

QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

3
Placebo: Phosphate buffered salineDRUG

Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

4

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
  • Brain MRI consistent with Alzheimer Disease
  • Concurent use of Chloniesterase inhibitor or memantine allowed if stable

You may not qualify if:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI
  • Clinically significant systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Groupe Hospitalier Pitie-Salpetriere

Paris, Cedex 13 (mri), 75651, France

Location

Hôpital Pitié-Salpétrière

Paris, Paris, 75651, France

Location

Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources

Bordeaux, 33076, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHRU de Lille

Lille (mri), 59037, France

Location

Hôpital Sainte-Marguerite

Marseille, 13385, France

Location

CHU Hôpital Gui de Chaulliac

Montpellier, 34295, France

Location

Groupe Hospitalier Broca-La Rochefoucauld

Paris, 75013, France

Location

Clinique de L'Union

St.-Jean, 31240, France

Location

Hôpital LA GRAVE

Toulouse, 31059, France

Location

Chru Purpan

Toulouse, 31300, France

Location

Clinique PASTEUR

Toulouse, 31300, France

Location

Unversitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

Berlin, 14050, Germany

Location

Zentralinstitut fuer Seelische Gesundheit

Frankenthal, 67227, Germany

Location

Klinik fuer Psychiatrie und Psychotherapie

Göttingen, 37075, Germany

Location

Zentralinstitut fuer Seelische Gesundheit

Mannheim, 68159, Germany

Location

Technische Universitaet Muenchen, Klinikum rechts der Isar

München, 81675, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Universitaetsklinikum Muenster

Münster, 48165, Germany

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinico y Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

    PMID: 26967206DERIVED

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

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

May 24, 2007

First Posted

May 28, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 1, 2016

Results First Posted

January 1, 2016

Record last verified: 2015-11

Locations

ES(4)FR(12)DE(8)