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Mild Cognitive ImpairmentPhase 2RECALLNCT00242593

Rosiglitazone Effects on Cognition for Adults in Later Life

A Phase 2 study testing Rosiglitazone in people with Mild Cognitive Impairment, run by University of Washington at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Rosiglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
3 sitesUnited States
Study dates
Jun 2006to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UCLA Alzheimer's Disease Center

    Los Angeles, California, 90095

  • Banner Alzheimer Institute

    Phoenix, Arizona, 85006

  • University of Washington/VA Puget Sound Health Care System

    Seattle/Tacoma, Washington, 98108

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Rosiglitazone
Keywords
cognition disorders, Alzheimer's disease, memory
Medical subject headings
Cognitive Dysfunction, Cognition Disorders, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosiglitazoneDrug

    Also called Avandia

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

Study groups in NCT00242593
Study groupRoleWhat they receive
AExperimentaloral rosiglitazone 4 mg twice daily for 18 months
Receives: Drug: Rosiglitazone
BPlacebo comparatorplacebo pill twice daily for 18 months
Receives: Drug: Rosiglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive measures: delayed list recall, Stroop Interference test

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

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

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

  3. MRI outcome: Whole brain and medial temporal lobe atrophy rate

    Measured: baseline and 18 months

Secondary outcomes (1)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2005 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00242593
Sponsor's protocol ID
IA0087
Other IDs
1R01AG025502-01A1
Acronym
RECALL
Status last verified
Aug 2011
First submitted
19 Oct 2005
Last updated
5 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

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

    PubMed 10954962

  • 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.

    PubMed 11160777

  • 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.

    PubMed 14568809

  • 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.

    PubMed 11306609

  • 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.

    PubMed 12467491

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosiglitazone in people with Mild Cognitive Impairment, run by University of Washington at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive measures: delayed list recall, Stroop Interference test (time frame: every 6 months for 18 months, again 2 at months post-treatment (20 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00242593, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.

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