NCT00242593

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

5.5 years

First QC Date

October 19, 2005

Last Update Submit

August 4, 2011

Conditions

Mild Cognitive Impairment

Keywords

cognition disordersAlzheimer's diseasememory

Outcome Measures

Primary Outcomes (3)

  • Cognitive measures: delayed list recall, Stroop Interference test

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

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

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

  • MRI outcome: Whole brain and medial temporal lobe atrophy rate

    baseline and 18 months

Secondary Outcomes (1)

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

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

Study Arms (2)

A

EXPERIMENTAL

oral rosiglitazone 4 mg twice daily for 18 months

Drug: Rosiglitazone

B

PLACEBO COMPARATOR

placebo pill twice daily for 18 months

Drug: Rosiglitazone

Interventions

RosiglitazoneDRUG

4 mg twice daily oral rosiglitazone or placebo pill for 18 months

Also known as: Avandia
AB

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Banner Alzheimer Institute

Phoenix, Arizona, 85006, United States

Location

UCLA Alzheimer's Disease Center

Los Angeles, California, 90095, United States

Location

University of Washington/VA Puget Sound Health Care System

Seattle/Tacoma, Washington, 98108, United States

Location

Related Publications (5)

  • Goldstein BJ. Rosiglitazone. Int J Clin Pract. 2000 Jun;54(5):333-7.

    PMID: 10954962BACKGROUND

  • Mudaliar S, Henry RR. New oral therapies for type 2 diabetes mellitus: The glitazones or insulin sensitizers. Annu Rev Med. 2001;52:239-57. doi: 10.1146/annurev.med.52.1.239.

    PMID: 11160777BACKGROUND

  • Lopez OL, Jagust WJ, Dulberg C, Becker JT, DeKosky ST, Fitzpatrick A, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Risk factors for mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 2. Arch Neurol. 2003 Oct;60(10):1394-9. doi: 10.1001/archneur.60.10.1394.

    PMID: 14568809BACKGROUND

  • Gasparini L, Gouras GK, Wang R, Gross RS, Beal MF, Greengard P, Xu H. Stimulation of beta-amyloid precursor protein trafficking by insulin reduces intraneuronal beta-amyloid and requires mitogen-activated protein kinase signaling. J Neurosci. 2001 Apr 15;21(8):2561-70. doi: 10.1523/JNEUROSCI.21-08-02561.2001.

    PMID: 11306609BACKGROUND

  • Watson GS, Craft S. The role of insulin resistance in the pathogenesis of Alzheimer's disease: implications for treatment. CNS Drugs. 2003;17(1):27-45. doi: 10.2165/00023210-200317010-00003.

    PMID: 12467491BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionCognition DisordersAlzheimer Disease

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Suzanne Craft, PhD

    University of Washington/VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

June 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

US(3)