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Alzheimer DiseasePhase 2NCT00982202

Pioglitazone in Alzheimer Disease

A Phase 2 study testing pioglitazone in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
2 sitesUnited States
Study dates
Jan 2002to Jan 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44120

Other trials in United States

About this study

Official title: Pioglitazone in Alzheimer Disease Progression

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.

Read the 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.

Being tested
pioglitazone, Placebo
Keywords
PPAR-gamma, inflammation
Medical subject headings
Alzheimer Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pioglitazoneDrug

    Also called Actos

    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

  • PlaceboDrug

    1 to 3 tablets daily for ~18 months

Study groups in NCT00982202
Study groupRoleWhat they receive
PGZExperimentalNot described
Receives: Drug: pioglitazone
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events

    Measured: baseline, monthly for 1 year, then 15 and 18 months

Secondary outcomes (5)

  1. Laboratory abnormalities

    Measured: baseline, monthly for 1 year, then 15 and 18 months

  2. Cognition

    Measured: baseline, 3, 6, 9, 12, 15, and 18 months

  3. Activities of Daily Living (ADL)

    Measured: baseline, 3, 6, 9, 12, 15, and 18 months

  4. Behavior

    Measured: baseline, 3, 6, 9, 12, 15, and 18 months

  5. Global function

    Measured: baseline, 3, 6, 9, 12, 15, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2009 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00982202
Sponsor's protocol ID
IA0168
Other IDs
1R01AG018905
Status last verified
Sep 2009
First submitted
22 Sep 2009
Last updated
23 Sep 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Heneka MT, Sastre M, Dumitrescu-Ozimek L, Hanke A, Dewachter I, Kuiperi C, O'Banion K, Klockgether T, Van Leuven F, Landreth GE. Acute treatment with the PPARgamma agonist pioglitazone and ibuprofen reduces glial inflammation and Abeta1-42 levels in APPV717I transgenic mice. Brain. 2005 Jun;128(Pt 6):1442-53. doi: 10.1093/brain/awh452. Epub 2005 Apr 7.

    PubMed 15817521

  • Jiang Q, Heneka M, Landreth GE. The role of peroxisome proliferator-activated receptor-gamma (PPARgamma) in Alzheimer's disease: therapeutic implications. CNS Drugs. 2008;22(1):1-14. doi: 10.2165/00023210-200822010-00001.

    PubMed 18072811

  • Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007 Sep 12;298(10):1180-8. doi: 10.1001/jama.298.10.1180.

    PubMed 17848652

  • Geldmacher DS, Fritsch T, McClendon MJ, Landreth G. A randomized pilot clinical trial of the safety of pioglitazone in treatment of patients with Alzheimer disease. Arch Neurol. 2011 Jan;68(1):45-50. doi: 10.1001/archneurol.2010.229. Epub 2010 Sep 13.

    PubMed 20837824

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pioglitazone in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (time frame: baseline, monthly for 1 year, then 15 and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982202, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.

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