Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

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 Alzheimers Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498602
• Other study ID #: 3134K1-2201
• Secondary ID: B2571005
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: November 30, 2015
• Start date: November 2007
• Est. completion date: February 2013

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of mild to moderate Alzheimer`s disease

• Age 50-85

• Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion Criteria:

• Significant Neurological Disease

• Major psychiatric disorder

• Clinically significant systemic illness Other exclusion criteria apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• ACC-001 + QS-21
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
• QS-21
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52

Other:
• Diluent: Phosphate Buffered Saline
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52

Biological:
• ACC-001
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52

Locations

Country	Name	City	State
United States	The Memory Clinic	Bennington	Vermont
United States	The Pharmacy	Bennington	Vermont
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Pharmcare USA	Edison	New Jersey
United States	MD Clinical	Hallandale Beach	Florida
United States	General Clinical Research Center	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Columbia Univ/Taub Institute Irving Ctr for Clinical Researc	New York	New York
United States	CUMC Research Pharmacy	New York	New York
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Butler Hospital	Providence	Rhode Island
United States	University of California - San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Barnes-Jewish Hospital	St. Louis	Missouri
United States	Barrnes-Jewish Hospital at Washington University	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Banner Boswell Medical Center	Sun City	Arizona
United States	Sun Health Research Institute	Sun City	Arizona
United States	General Clinical Research Center	Washington	District of Columbia
United States	GUMC	Washington	District of Columbia
United States	Palm Beach Neurology - Premiere Research Institute	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No
Secondary	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.	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No
Secondary	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	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No

External Links

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