Rosiglitazone Effects on Cognition for Adults in Later Life (RECALL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00242593
First received: October 19, 2005
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to determine the effects of the insulin-sensitizing medication rosiglitazone on attention and memory skills in older adults with mild cognitive impairment (MCI). The study also will examine the effects of this medication on brain structures that support memory and other thinking abilities, and on biological markers associated with inflammation, insulin resistance, and cardiovascular disease.


Condition Intervention Phase
Mild Cognitive Impairment
Drug: Rosiglitazone
Phase 2

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
Official Title: The Effects of Rosiglitazone on Cognition in Patients With MCI

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Cognitive measures: delayed list recall, Stroop Interference test [ Time Frame: every 6 months for 18 months, again 2 at months post-treatment (20 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • MRI outcome: Whole brain and medial temporal lobe atrophy rate [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
oral rosiglitazone 4 mg twice daily for 18 months
Drug: Rosiglitazone
4 mg twice daily oral rosiglitazone or placebo pill for 18 months
Other Name: Avandia
Placebo Comparator: B
placebo pill twice daily for 18 months
Drug: Rosiglitazone
4 mg twice daily oral rosiglitazone or placebo pill for 18 months
Other Name: Avandia

Detailed Description:

The study will examine the effects of the insulin-sensitizing agent rosiglitazone on learning and memory for 120 patients diagnosed with MCI. Participants will be randomized to an 18-month trial of rosiglitazone or placebo, followed by a 2-month washout period. At screening and at treatment month 18, all participants will undergo an oral glucose tolerance test (OGTT) to estimate pre- and post- treatment insulin sensitivity and β-cell function. Cognitive measures and blood samples for biochemical assays will be obtained at baseline, treatment months 6, 12, and 18, and washout (two months after completing treatment).

During treatment, participants will have safety labs drawn and receive physical assessment of any adverse events, changes in health status, or changes in medication; initially these visits will be done at weeks 2 and 4, and then every three months. For months in which a safety visit is not scheduled, telephone monitoring to assess any health concerns will be conducted.

All participants enrolled in the primary study will be approached to participate in an MRI substudy; patients will undergo serial brain MRI before treatment and following 18 months of rosiglitazone or placebo, using three-dimensional T1-weighted images. Comparison of MCI patients receiving rosiglitazone and placebo will be conducted to determine whether the rate of medial temporal lobe (MTL) and whole brain atrophy is altered following treatment.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242593

Locations
United States, Arizona
Banner Alzheimer Institute
Phoenix, Arizona, United States, 85006
United States, California
UCLA Alzheimer's Disease Center
Los Angeles, California, United States, 90095
United States, Washington
University of Washington/VA Puget Sound Health Care System
Seattle/Tacoma, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
GlaxoSmithKline
Investigators
Principal Investigator: Suzanne Craft, PhD University of Washington/VA Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Suzanne Craft, PhD, University of Washington School of Medicine
ClinicalTrials.gov Identifier: NCT00242593     History of Changes
Other Study ID Numbers: IA0087, 1R01AG025502-01A1, 1RO1 AG025502-01A1
Study First Received: October 19, 2005
Last Updated: August 4, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
cognition disorders
Alzheimer's disease
memory

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014