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Pioglitazone in Alzheimer Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982202
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : September 23, 2009
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date September 23, 2009
Study Start Date  ICMJE January 2002
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
Frequency of adverse events [ Time Frame: baseline, monthly for 1 year, then 15 and 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • Laboratory abnormalities [ Time Frame: baseline, monthly for 1 year, then 15 and 18 months ]
  • Cognition [ Time Frame: baseline, 3, 6, 9, 12, 15, and 18 months ]
  • Activities of Daily Living (ADL) [ Time Frame: baseline, 3, 6, 9, 12, 15, and 18 months ]
  • Behavior [ Time Frame: baseline, 3, 6, 9, 12, 15, and 18 months ]
  • Global function [ Time Frame: baseline, 3, 6, 9, 12, 15, and 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pioglitazone in Alzheimer Disease
Official Title  ICMJE Pioglitazone in Alzheimer Disease Progression
Brief Summary This study was designed to assess the safety and tolerability of pioglitazone, an approved drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also designed to generate preliminary information on whether pioglitazone might slow progression of Alzheimer's disease.
Detailed Description Inflammatory processes are important in the progressive loss of memory and thinking skills in Alzheimer's disease (AD). Laboratory studies show that drugs that bind to a protein known as "Peroxisome Proliferator Activated Receptor-gamma (PPARgamma)" act to reduce inflammatory responses in brain cells known as microglia when they are exposed to amyloid peptide, a major part of AD pathology. Therefore, drugs that activate PPARgamma have great potential for reducing the progression of AD. Pioglitazone (PGZ) activates PPARgamma and has shown favorable clinical experiences and safety profiles in patients with diabetes. This is a pilot study to determine the safety and tolerability of PGZ in patients with AD. Another goal of the study is to assess how clinical measures of cognition, daily function, and behavior might respond to PGZ treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: pioglitazone
    15mg tablet daily, increase by one pill at one-week intervals based on reported tolerability; maintain best tolerated dose (1 to 3 tablets daily) for ~18months
    Other Name: Actos
  • Drug: Placebo
    1 to 3 tablets daily for ~18 months
Study Arms  ICMJE
  • Experimental: PGZ
    Intervention: Drug: pioglitazone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2009)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CT or MRI since disease onset excluding structural lesions sufficient to account for the participant's dementia
  • Mini-Mental State Exam (MMSE) score between 12 and 26, inclusively
  • Clinical Dementia Rating (CDR) score of 1 or 2 (mild to moderate AD severity) at both screening and baseline
  • Women must be 2-years post-menopausal or surgically sterile.
  • Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane); vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures
  • Concomitant medications: Participants may be on stable doses of cholinesterase inhibitors for 90 days prior to screening (may not be started during the trial); antidepressant or antipsychotic medications are acceptable if symptoms are controlled and therapy is at stable dosage for at least 30 days prior to screening; vitamin E at 200 IU daily will be provided to all participants beginning at baseline/randomization (higher doses must be discontinued at the screening visit)

Exclusion Criteria:

  • Absence of a reliable caregiver who is willing to participate and comply with protocol responsibilities
  • Diabetes mellitus requiring medical therapy (diet-controlled diabetes is acceptable)
  • Acute or chronic liver failure, hepatitis within the last two years, or history of drug-induced liver transaminase elevations
  • Heart failure meeting New York Heart Association Grade III or IV criteria (i.e., functionally disabling)
  • Evidence of active gastrointestinal, renal, pulmonary, endocrine or cardiovascular system disease sufficient to cause cognitive impairment or interfere with past levels of daily function; participants with controlled hypertension (supine diastolic BP < 95mmHg), right bundle branch block (complete or partial) and pacemakers may be included in the study; participants with thyroid disease also may be included in the study, provided they are euthyroid on treatment
  • Active treatment for cancer or history of cancer within 3 years of screening (basal cell and squamous cells skin cancers are acceptable; incidental finding of carcinoma cells at transurethral prostate resection without subsequent medical or surgical therapy is acceptable)
  • Evidence of other psychiatric/neurologic disorders sufficient to be the primary source of cognitive impairment (i.e., stroke, idiopathic Parkinson's disease, schizophrenia, bipolar or unipolar depression, seizure disorder, head injury with loss of consciousness within the past year) or a modified Hachinski's ischemia score of 5 or greater; delusions, hallucinations or depression not successfully treated or not on stable medical therapy for these conditions 30 days prior to enrollment; known or suspected history (within the past 10 years) of alcoholism or drug misuse
  • Participants and/or caregivers who are unwilling or unable to fulfill the requirements of the study
  • Any condition which would make the participant or the caregiver, in the opinion of the investigator, unsuitable for the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982202
Other Study ID Numbers  ICMJE IA0168
1R01AG018905 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Geldmaher, MD, University of Virginia Health System
Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE Takeda Pharmaceuticals North America, Inc.
Investigators  ICMJE
Principal Investigator: David Geldmaher, MD University of Virginia Health System
PRS Account National Institute on Aging (NIA)
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP