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RECALL

UnknownPhase 2

Rosiglitazone Effects on Cognition for Adults in Later Life

The Effects of Rosiglitazone on Cognition in Patients With MCI

Lead sponsor

University of Washington

Asset

Rosiglitazone

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•Age ≥55

Primary endpoints

•Cognitive measures•Biological outcomes•MRI outcome

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

Nih1R01AG025502-01A1

Org study IDIA0087

NCT IDNCT00242593

Timeline

Milestones

Study first posted2005-10-20estimated

Study start2006-06 (month precision)

Last update posted2011-08-05estimated

Primary completion2011-12estimated (month precision)

Study completion2011-12estimated (month precision)

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•MCI diagnosis: Participants will be diagnosed with MCI by consensus of a team of physicians and neuropsychologists experienced in the diagnosis of MCI, using the Petersen (Petersen, 1999, 2001) criteria for amnestic MCI or multiple domain MCI with amnestic features:

a)the presence of subjective memory complaints, evaluated via detailed patient history and informant interview,

b)objective verification of memory impairment as measured by neuropsychological tests,

c)normal general cognitive function,

d)intact or only mildly impaired activities of daily living, and

e)absence of dementia per NINCDS/ADRDA and/or DSM-IV criteria

Exclusion criteria

The following exclusion criteria will be used, based on initial physical examination, medical history, lab work, and oral glucose tolerance test (OGTT) results:

•Diagnosis of diabetes or other relevant glucoregulatory disorders

•Use of any oral anti-diabetic compounds

•Clinically significant elevations in liver function

•Significant neurological disease that might affect cognition, other than MCI, including Alzheimer's disease, large-vessel stroke, Parkinson's disease, multiple sclerosis, recent severe head injury (loss of consciousness for more than 30 minutes in the past year), or remote head injury resulting in permanent cognitive or neurological sequelae

•History or current evidence of congestive heart failure (CHF)

•History of documented ischemic cardiac disease, i.e., angina, MI, angioplasty, stent, or CABG

•History of cardiac or vascular surgery, or significant arrhythmia within the last year; or planned major intervention such as cardiac surgery or stenting. A history of cardiac surgery for non-ischemic indications (i.e., valve repair or replacement) greater than one year prior to enrollment is not exclusionary if all other criteria are met

•Significant ECG abnormalities including heart rate less than 50 or greater than 100 beats per minute (dependent upon the individual's general health); any previously unrecognized arrhythmia requiring further intervention

•Significant peripheral edema at the time of screening

•Significant medical illness or organ failure, including but not limited to renal disease, hepatic disease, and unstable cardiac disease

•Regular current use of antipsychotic, anticonvulsive, anxiolytic, or sedative medications; antidepressant medications are not exclusionary, provided the individual does not have current major depression

•A current diagnosis of major depression or other significant psychiatric comorbidity

•Clinically significant anemia at the time of screening

•Fasting triglyceride level greater than 400

•Fasting glucose 125 or greater, or two-hour glucose value greater than 199 during the OGTT; participants will be notified if their fasting blood sugar (monitored every 3 months) exceeds 125, and they will be withdrawn from further participation if their fasting blood sugar exceeds 125 for two consecutive months

•For the MRI substudy, additional exclusion criteria include 1) previous exposure to work involving the cutting or grinding of metal, 2) the presence of a pacemaker, aneurysm clip, or other implanted metal device that would prohibit MRI procedures, and 3) significant history of claustrophobia

Endpoints (4)

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

Global cognition

Memory

Neuroimaging

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognitive measures: ADAS-cog total score, story recall verbal fluency, paired associate learning, SOPT, rating scales

Time frame:every 6 months for 18 months, again 2 at months post-treatment (20 months)

ADAS-Cog

descriptive

Memory

1 endpoint

Primary/protocol endpoint

Cognitive measures: delayed list recall, Stroop Interference test

Time frame:every 6 months for 18 months, again 2 at months post-treatment (20 months)

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

MRI outcome: Whole brain and medial temporal lobe atrophy rate

Time frame:baseline and 18 months

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Biological outcomes: plasma insulin, IDE, AB40, AB42, inflammatory cytokines, and F2-isoprostanes

Time frame:every 6 months for 18 months, again 2 at months post-treatment (20 months)

descriptive

Publications (5)

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.