ACCORD-MIND: Action to Control Cardiovascular Risk in D...

ACCORD-MIND: Action to Control Cardiovascular Risk in Diabetes--Memory in Diabetes

ACCORD-MIND: Action to Control Cardiovascular Risk in Diabetes--Memory in Diabetes
November 9, 2008
Clinicaltrials.gov

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)

Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00182910

Purpose
The purpose of this study is to test whether the rate of cognitive decline and structural brain change in people with diabetes treated with standard care guidelines is different than in people with diabetes treated with intensive care guidelines.

Condition Intervention Phase
Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Diabetes Mellitus
Coronary Disease
Drug: hypoglycemic agents
Drug: hydroxymethylglutaryl-CoA Reductase inhibitors
Drug: antihypertensive agents
Drug: fibrates
Phase III


Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes High Blood Pressure Memory

Drug Information available for: Calcium gluconate Clofibric acid

U.S. FDA Resources

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study

Official Title: Action to Control Cardiovascular Risk in Diabetes--Memory in Diabetes

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
Cognitive decline: rate of decline in tests of memory and executive function in the glycemic treatment group [ Time Frame: Baseline, 20 months and 40 months ] [ Designated as safety issue: No ]

MRI brain changes: total brain volume (cerebral atrophy) in the glycemic treatment group [ Time Frame: Baseline and 40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Cognitive decline: rate of decline in tests of memory and executive function in the blood pressure and lipid treatment groups over a 4 year period [ Time Frame: Baseline, 20 months and 40 months ] [ Designated as safety issue: No ]

MRI brain changes: total brain volume (cerebral atrophy) in the blood pressure treatment group over a 4 year period [ Time Frame: Baseline and 40 months ] [ Designated as safety issue: No ]

Enrollment: 2977
Study Start Date: October 2003
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1.: Active Comparator
Standard diabetes treatment--HbA1c Target 7.0-7.9% Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
2.: Experimental
Intensive diabetes treatment--HbA1c Target 6.0% Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
3.: Active Comparator
Standard lipid treatment--a statin for treatment of LDL-C Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: hydroxymethylglutaryl-CoA Reductase inhibitors
a statin for treatment of LDL-C
4.: Experimental
Intensive lipid treatment--a fibrate to raise HDL-C/lower triglyceride levels plus a statin for treatment of LDL-C Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: hydroxymethylglutaryl-CoA Reductase inhibitors
a statin for treatment of LDL-C
Drug: fibrates
to increase HDL with fibrates
5.: Active Comparator
Standard blood pressure treatment--target systolic blood pressure (SBP) of < 140 mm Hg Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: antihypertensive agents
diuretics, beta-blockers, calcium channel blockers, or ACE inhibitors
6.: Experimental
Intensive blood pressure treatment--target systolic blood pressure (SBP) of < 120 mm Hg Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: antihypertensive agents
diuretics, beta-blockers, calcium channel blockers, or ACE inhibitors

Detailed Description:
Type 2 diabetes and cognitive impairment are two of the most common chronic conditions found in persons 60 years and older. Approximately 18%-20% of older persons suffer from diabetes. And, in the general population, the prevalence of cognitive impairment, measured with the simple Mini-Mental State Exam, increases steadily from 5% at 65 years to 15% percent at 80 years of age. Many persons with cognitive impairment go on to develop dementia, which doubles in incidence and prevalence every additional 5 years of age. Studies suggest diabetes is one risk factor for cognitive impairment and dementia.

Further, the brains of people with diabetes are at risk for complications following repeated hypoglycemic events. Magnetic Resonance Imaging (MRI) provides a measure of the structural changes in the brain that form the anatomical substrate for cognitive decline and dementia. At present there are a few MRI studies showing people with diabetes have increased risk for brain atrophy and (mainly silent) lacunae.

The comparison of standard diabetes care with intensive diabetes care will be made in a sub-sample of 2800 people (including 640 for MRI) with diabetes currently participating in the ongoing National Heart Lung and Blood Institute (NHLBI) Action to Control Cardiovascular Risk in Diabetes (ACCORD). ACCORD is designed to evaluate whether more intensive glucose, blood pressure and lipid management can reduce cardiovascular disease in people with diabetes. Participants in ACCORD-MIND will have already been randomly assigned to either the intensive or standard diabetes care in the ACCORD trial, and will already have been randomized to either the blood pressure or lipid intervention arms (see NCT00000620). ACCORD-MIND will test these patients for cognitive function and changes in brain structure.

Tests of cognitive function measure memory and executive function, which includes speed of processing, attention, planning, and concentration. They are indicators of how well a person performs various tasks in daily life. Cognitive impairment is also predictive of future onset of dementia. In diabetes, cognitive impairment may compromise an individual's ability to manage his/her disease, an important factor that should be incorporated into an analysis of the trial efficacy.

MRI is a safe, non-invasive method to assess the structural characteristics of the brain. With MRI, investigators may begin to identify vascular lesions and brain atrophy that form the anatomical basis for cognitive changes that may be associated with the ACCORD treatments.

Eligibility
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Fulfills criteria for inclusion in the ACCORD main trial
At least 55 years of age
English or Spanish is usual language
Agrees to identify a personal contact who has frequent interaction with participant in order to provide data as needed
Exclusion Criteria:

Fulfills criteria for exclusion in the ACCORD main trial
Cancer diagnosed and treated within the past 5 years that, in the judgment of clinical study staff, would compromise a participant's ability to comply with the protocol and complete the trial (exceptions would include skin cancer, early-stage prostrate cancer, etc.).
Any condition that, in the judgment of the clinical study staff, would preclude full participation in the study (e.g. clinical evidence of dementia, excessive use of alcohol, any visual or hearing impairment that could compromise assessment of cognitive function).
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00182910

Locations

United States, Maryland
National Institute on Aging
Bethesda, Maryland, United States, 20892

United States, Minnesota
Minnesota-Iowa Network, Hennepin County Medical Center
Minneapolis, Minnesota, United States

United States, New York
Northeast Network, Columbia University
New York, New York, United States

United States, North Carolina
Southeast Network, Wake Forest University
Winston-Salem, North Carolina, United States

United States, Ohio
Ohio-Michigan Network, University Hospitals of Cleveland
Cleveland, Ohio, United States

United States, Washington
Western Network, University of Washington
Seattle, Washington, United States

Canada, Ontario
Canada Network, McMaster Medical Centre
Hamilton, Ontario, Canada

Sponsors and Collaborators

National Institute on Aging (NIA)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Lenore J. Launer, PhD Chief, Neuroepidemiology Section, Laboratory of Epidemiology, Demography, and Biometry, National Institute on Aging, National Institutes of Health

More Information

ACCORD-MIND (Memory IN Diabetes) Sub Study Public Information

Publications of Results:

Williamson JD, Miller ME, Bryan RN, Lazar RM, Coker LH, Johnson J, Cukierman T, Horowitz KR, Murray A, Launer LJ; ACCORD Study Group. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. Epub 2007 Apr 12.

Other Publications:

Launer LJ, Oudkerk M, Nilsson LG, Alperovitch A, Berger K, Breteler MM, Fuhrer R, Giampaoli S, Nissinen A, Pajak A, Sans S, Schmidt R, Hofman A. CASCADE: a European collaborative study on vascular determinants of brain lesions. Study design and objectives. Neuroepidemiology. 2000 May-Jun;19(3):113-20.

Launer LJ. Diabetes and brain aging: epidemiologic evidence. Curr Diab Rep. 2005 Feb;5(1):59-63. Review.

Responsible Party: LEDB/IRP/NIA ( Lenore J. Launer )
Study ID Numbers: IA0080
First Received: September 9, 2005
Last Updated: June 26, 2008
ClinicalTrials.gov Identifier: NCT00182910
Health Authority: United States: Federal Government


Keywords provided by National Institute on Aging (NIA):
Cognitive Impairment
MCI
dementia
Alzheimer's disease

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Clofibric Acid
Hyperlipidemias
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Alzheimer Disease
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis
Ischemia
Coronary Disease
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Dementia
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Cardiovascular Diseases
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2008