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

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ClinicalTrials.gov Identifier: NCT00955409
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: ACC-001(3µg) + QS21 Biological: ACC-001(10µg) + QS21 Biological: ACC-001(30µg) + QS21 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2009
Actual Primary Completion Date : December 17, 2013
Actual Study Completion Date : December 17, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACC-001(3µg) + QS21
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
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
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




Primary Outcome Measures :
  1. Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: 24 months ]
    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.


Other Outcome Measures:
  1. 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 [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ]
    IGM was not statistically analyzed.

  2. 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) [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ]
    IgG subtypes were not assessed

  3. 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955409


Locations
Show Show 17 study locations
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00955409    
Other Study ID Numbers: 3134K1-2203
B2571007 ( Other Identifier: Alias Study Number )
2009-010922-21 ( EudraCT Number )
First Posted: August 10, 2009    Key Record Dates
Results First Posted: March 25, 2021
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Saponin QA-21V1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs