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Home > "M" Clinical Trials Conditions > Memory Impairment Study (Mild Cognitive Impairment Study)  Memory Impairment Study (Mild Cognitive Impairment Study)
Memory Impairment Study (Mild Cognitive Impairment Study)
For Condition: Alzheimer Disease
Status: No longer recruiting
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
Details: This clinical trial will be a multicenter, randomized, double-blind, placebo- controlled, parallel-group study of vitamin E and donepezil in 720 subjects with mild cognitive impairment (MCI). Subjects will be randomized to one of three treatment groups (240 subjects per treatment group): 1) Placebo vitamin E and placebo donepezil plus a multivitamin daily. 2) Vitamin E (2,000 I) and placebo donepezil plus a multivitamin daily.3) Donepezil (10 mg) and placebo vitamin E plus a multivitamin daily. The study will be conducted over three years, with clinical evaluations every 3 months for the first 6 months and then every 6 months. Subjects randomized to donepezil will start a dose of 5 mg daily. Donepezil will be increased to 10 mg after six weeks. Subjects randomized to vitamin E will start at 1,000 I daily. The dose of Vitamin E will be increased to 2,000 I after six weeks. There will be a 12-month recruitment period. The primary endpoint will be time to development of Probable or Possible AD according to NINCDS-ADRDA criteria. Upon determination of a clinical diagnosis of AD, documentation will be sent to the ADCS Coordinating Center and forwarded to the Central Review Committee for verification. Upon verification, of conversion to diagnosis of AD, subjects will stop taking the donepezil study medication or its corresponding placebo, without breaking the blind, and will be offered open label donepezil at a scheduled visit one month after the prior diagnostic visit. Donepezil will be offered to subjects who convert to AD until the subject completes three years from the baseline visit. Based on an estimated incidence of AD of 15% per year, the study has 85% power to detect a 33% or greater reduction in conversion to AD over 3 years. Secondary outcome measures will include change on the Alzheimer's Disease Assessment Scale (ADAS-COG), the Neuropsychological Battery, the Mini-Mental State Exam (MMSE), Clinical Dementia Rating Scale (CDR), the Global Deterioration Scale (GDS), ADCS- Activities of Daily Living Inventory (ADCS-ADL), a Pharmacoeconomics scale, and a Quality of Life scale. Compliance will be monitored through the measurement of alpha-tocopherol levels and pill counts at each visit.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 55 Years/90 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Memory complaints and memory difficulties which are verified by an informant. - Abnormal memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25): a) less than or equal to 8 for 16 or more years of education, b) less than or equal to 4 for 8-15 years of education, c) less than or equal to 2 for 0-7 years of education. - Mini-Mental Exam score between 24 and 30 (inclusive) (Exceptions may be made for subjects with less than 8 years of education at the discretion of the project director.). - Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5. - General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit. - No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4. - Age between 55 and 90 (inclusive). - Permitted medications stable for at least 1 month prior to screening. In particular: a) Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 2 years). b) Estrogen replacement therapy is permissible. c) Ginkgo biloba is permissible, but discouraged. - Hamilton Depression rating scale score of less than or equal to 12 on the 17-item scale. - Informant is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), agrees to monitor administration of study drug, observe for adverse events, and accompany the subject to all clinic visits for the duration of the protocol. - CT or MRI scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. A lacune in a non-critical brain area which is not believed to contribute to the subject's cognitive impairment is permissible. - Adequate visual and auditory acuity to allow neuropsychological testing. - Good general health with no additional diseases expected to interfere with the study. - Normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study. - ECG without clinically significant abnormalities that would be expected to interfere with the study. - Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). - Agreement not to take other vitamin supplements (including Vitamin E), multivitamins, other than those provided by the study. Exclusion Criteria: - Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. - Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years. - Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol. - History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). - History of schizophrenia (DSM IV criteria). - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including: a) History of systemic cancer within the last 5 years (non-metastatic skin cancers are acceptable). b) History of myocardial infarction within the past year or unstable or severe cardiovascular disease including angina or CHF with symptoms at rest. c) Clinically significant obstructive pulmonary disease or asthma. d) Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years. e) Clinically significant laboratory test abnormalities on the battery of screening tests (hematology, prothrombin time, chemistry, urinalysis, ECG). f) Insulin-requiring diabetes or uncontrolled diabetes mellitus. g) Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100). h) History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years. - Medications a) Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbituates within 4 weeks prior to screening. e) Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening). f) Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening. - Vitamin Supplements a) Use of vitamin supplements other than standard multivitamin included as part of the treatment intervention used in this protocol within 2 weeks prior to screening. - Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g. tacrine, donepezil, or other newly approved medications). - Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening. - Subjects who, in the investigator's opinion, will not comply with study procedures.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonThal, Principal Investigator, Alzheimer's Disease Cooperative Study
University of Nevada
Las Vegas, Nevada, 89102
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Memory Disorders Institute
Lakehurst, New Jersey, 08733
United States
University of South Florida
Tampa, Florida, 33612
United States
Emory University
Atlanta, Georgia, 30329
United States
Indiana University
Indianapolis, Indiana, 46202-5111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962
United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646
United States
University of British Columbia
Vancouver, British Columbia, V6T 2B5
Canada
St. Joseph's Health Center
London, Ontario, N6A 4V2
Canada
University of Arizona
Tucson, Arizona, 857245023
United States
UC Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285
United States
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, 33486
United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201
United States
University of California, Los Angeles
Los Angeles, California, 90095-1769
United States
Premiere Research Institute
West Palm Beach, Florida, 33407
United States
Princeton Biomedical - Toms River
Toms River, New Jersey, 08755
United States
Columbia University
New York City, New York, 11032
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States
University of Kentucky
Lexington, Kentucky, 40536-0230
United States
East Bay Institute
Martinez, California, 94553
United States
Brown University
Pawtucket, Rhode Island, 02860
United States
Medical University of South Carolina
North Charleston, South Carolina, 29406
United States
University of Washington
Seattle, Washington, 98108
United States
Affiliated Research Instiute
San Diego, California, 92018
United States
Southern Illinois University
Springfield, Illinois, 62702
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Univ. of New Mexico
Albuquerque, New Mexico, 89108
United States
Burke Medical Research Institute
White Plains, New York, 10605
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Baumel-Eisner Neuromedical Institute, Ft. Lauderdale
Ft. Lauderdale, Florida, 33321
United States
ClinSearch, Inc.
Summit, New Jersey, 07901
United States
Washington University
St. Louis, Missouri, 63110
United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of California, San Francisco
San Francisco, California, 94115
United States
Elizabeth Bruyere Centre
Ottawa, Ontario, K1N 5C8
Canada
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44120-1013
United States
Princeton Biomedical Research, PA
Princeton, New Jersey, 08540
United States
Alzheimer's Research Corp.
West Long Branch, New Jersey, 07764
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Johns Hopkins University
Baltimore, Maryland, 21224
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Geriatric Medicine Research Group
Halifax, Nova Scotia, B3H 2E1
Canada
Northwestern University
Chicago, Illinois, 60611
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
MCP Hahnemann
Philadelphia, Pennsylvania, 19129
United States
University of Calgary
Calgary, Alberta, T2N 4N1
Canada
Fredericton Medical Clinic
Fredericton, New Brunswick, E3B 6H5
Canada
McGill Centre for Studies in Aging
Verdun, Quebec, H4H 1R3
Canada
Barrow Neurological Group
Phoenix, Arizona, 85013
United States
Yale University
New Haven, Connecticut, 06520
United States
Jewish General Hospital Memory Clinic
Montreal, Quebec, H3T 1E2
Canada
University of Southern California
Los Angeles, California, 90033
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Sunnybrook Health Science Center
Toronto, Ontario, M4N 3M5
Canada
Mount Sinai Medical Center
New York City, New York, 10029
United States
Baumel-Eisner Neuromedical Institute, MiamiBeach
Miami, Florida, 33154
United States
Clinical Neuroscience Research Unit
Burlington, Vermont, 05401
United States
NYU Medical Center
New York City, New York, 10016
United States
Wein Center
Miami, Florida, 33140
United States
University of California, San Diego
San Diego, California, 92093-0949
United States
Augusta VA Medical Center
Augusta, Georgia, 30904
United States
University of Rochester
Rochester, New York, 14620
United States
Mayo Clinic
Rochester, Minnesota, 55901-0144
United States
SUNY Stony Brook
Stony Brook, New York, 11794-8121
United States
University of Miami
Port Charlotte, Florida, 33952
United States
Additional Information:
Study ID Numbers: IA0011; 3U01AG10483-08S2
Study Start Date: March 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000173
Other Alzheimer Disease Studies:
1. Valproate in Dementia (VALID)
2. Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study
3. Bathing persons with Alzheimer's disease aT Home (The BATH Study)
4. Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder
5. Alzheimer's Disease Prevention Trial
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Quebec Clinical Trials
Other Verdun Clinical Trials
Memory Impairment Study (Mild Cognitive Impairment Study)
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