Pioglitazone in Alzheimer Disease - Alzheimer’s Disease & Related Dementias Atlas

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG018905

Org study IDIA0168

NCT IDNCT00982202

Timeline

Milestones

Study start2002-01 (month precision)

Primary completion2005-01actual (month precision)

Study completion2005-01actual (month precision)

Study first posted2009-09-23estimated

Last update posted2009-09-23estimated

Assets

Drug assets

Pioglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

3

Function / daily living

1

Behavior / neuropsychiatric

1

Safety / tolerability / PK

1

Function / daily living

1 endpoint

Secondary/protocol endpoint

Activities of Daily Living (ADL)

Time frame:baseline, 3, 6, 9, 12, 15, and 18 months

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Behavior

Time frame:baseline, 3, 6, 9, 12, 15, and 18 months

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Frequency of adverse events

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

event count, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Laboratory abnormalities

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

descriptive

Secondary/protocol endpoint/low confidence

Cognition

Time frame:baseline, 3, 6, 9, 12, 15, and 18 months

descriptive

Secondary/protocol endpoint/low confidence

Global function

Time frame:baseline, 3, 6, 9, 12, 15, and 18 months

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.