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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 + QS-21
ACC-001
QS-21
Placebo: Phosphate buffered saline
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, active immunization

Eligibility Criteria

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

Inclusion Criteria:

  • 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
  • Other inclusion criteria apply

Exclusion Criteria:

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

Sites / Locations

  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital Pitié-Salpétrière
  • Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
  • CHRU de Lille
  • CHRU de Lille
  • Hôpital Sainte-Marguerite
  • CHU Hôpital Gui de Chaulliac
  • Groupe Hospitalier Broca-La Rochefoucauld
  • Clinique de L'Union
  • Hôpital LA GRAVE
  • Chru Purpan
  • Clinique PASTEUR
  • Unversitätsklinikum Freiburg
  • Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
  • Zentralinstitut fuer Seelische Gesundheit
  • Klinik fuer Psychiatrie und Psychotherapie
  • Zentralinstitut fuer Seelische Gesundheit
  • Universitaetsklinikum Muenster
  • Universitaetsklinikum Muenster
  • Technische Universitaet Muenchen, Klinikum rechts der Isar
  • Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinico y Provincial
  • Hospital Universitario Clinico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

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

arm 2: ACC-001

arm 3: QS-21

Drug: Phosphate Buffered Saline (PBS)

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

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
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.
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
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
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)
IgG subtypes were not assessed

Full Information

First Posted
May 24, 2007
Last Updated
November 30, 2015
Sponsor
Pfizer
Collaborators
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00479557
Brief Title
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, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease, active immunization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
Arm Title
2
Arm Type
Active Comparator
Arm Description
arm 2: ACC-001
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
arm 3: QS-21
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Drug: Phosphate Buffered Saline (PBS)
Intervention Type
Biological
Intervention Name(s)
ACC-001 + QS-21
Intervention Description
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Intervention Type
Biological
Intervention Name(s)
ACC-001
Intervention Description
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
Intervention Type
Biological
Intervention Name(s)
QS-21
Intervention Description
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Intervention Type
Drug
Intervention Name(s)
Placebo: Phosphate buffered saline
Intervention Description
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
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
approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Secondary Outcome Measure Information:
Title
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
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
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Title
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
Description
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Time Frame
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Description
IgG subtypes were not assessed
Time Frame
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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: 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 Other inclusion criteria apply Exclusion Criteria: Significant Neurological Disease other than Alzheimer's disease Major psychiatric disorder Contraindication to undergo brain MRI Clinically significant systemic illness Other exclusion criteria apply
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
Groupe Hospitalier Pitie-Salpetriere
City
Paris
State/Province
Cedex 13 (MRI)
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Pitié-Salpétrière
City
Paris Cedex 13
State/Province
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU de Lille
City
Lille (MRI)
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Sainte-Marguerite
City
MARSEILLE cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Hôpital Gui de Chaulliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Groupe Hospitalier Broca-La Rochefoucauld
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Clinique de L'Union
City
St JEAN
ZIP/Postal Code
31240
Country
France
Facility Name
Hôpital LA GRAVE
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Chru Purpan
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Clinique PASTEUR
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Unversitätsklinikum Freiburg
City
Freiburg
State/Province
Baden- Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Zentralinstitut fuer Seelische Gesundheit
City
Frankenthal
ZIP/Postal Code
67227
Country
Germany
Facility Name
Klinik fuer Psychiatrie und Psychotherapie
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Zentralinstitut fuer Seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48165
Country
Germany
Facility Name
Technische Universitaet Muenchen, Klinikum rechts der Isar
City
München
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
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26967206
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-200&StudyName=Study%20Evaluating%20Safety%2C%20Tolerability%2C%20And%20Immunogenicity%20Of%20ACC-001%20In%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease
Description
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Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

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