Rosiglitazone Effects on Cognition for Adults in Later Life

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00242593
• Date of registration: 19/10/2005
• Primary sponsor: University of Washington
• Public title: Rosiglitazone Effects on Cognition for Adults in Later Life RECALL
• Scientific title: The Effects of Rosiglitazone on Cognition in Patients With MCI
• Date of first enrolment: June 2006
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00242593
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Suzanne Craft, PhD
• Affiliation: University of Washington/VA Puget Sound Health Care System

Key inclusion & exclusion criteria

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



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Mild Cognitive Impairment

Intervention(s)

Drug: Rosiglitazone

Primary Outcome(s)

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)]

Cognitive measures: delayed list recall, Stroop Interference test [Time Frame: every 6 months for 18 months, again 2 at months post-treatment (20 months)]

MRI outcome: Whole brain and medial temporal lobe atrophy rate [Time Frame: baseline and 18 months]

Secondary Outcome(s)

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)]

Secondary ID(s)

1R01AG025502-01A1

1RO1 AG025502-01A1

IA0087

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

National Institute on Aging (NIA)