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: NCT00479557 |
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Recruitment Status :
Completed
First Posted : May 28, 2007
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
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Sponsor:
Pfizer
Collaborator:
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease | Biological: ACC-001 + QS-21 Biological: ACC-001 Biological: QS-21 Drug: Placebo: Phosphate buffered saline | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 86 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, 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 Start Date : | May 2007 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
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Biological: ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 |
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Active Comparator: 2
arm 2: ACC-001
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Biological: ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12 |
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Placebo Comparator: 3
arm 3: QS-21
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Biological: QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 |
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Placebo Comparator: 4
Drug: Phosphate Buffered Saline (PBS)
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Drug: Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12 |
Primary Outcome Measures :
- Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ 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. ]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 [ Time Frame: Baseline, Week 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 [ Time Frame: Baseline, Week 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) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]IgG subtypes were not assessed
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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:
- 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
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): NCT00479557
Locations
Show 24 study locations
Sponsors and Collaborators
Pfizer
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00479557 |
| Other Study ID Numbers: |
3134K1-200 B2571004 ( Other Identifier: Alias Study Number ) 2006-002061-39 ( EudraCT Number ) |
| First Posted: | May 28, 2007 Key Record Dates |
| Results First Posted: | January 1, 2016 |
| Last Update Posted: | January 1, 2016 |
| Last Verified: | November 2015 |
Keywords provided by Pfizer:
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Alzheimer's Disease active immunization |
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 |