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Sponsored by: |
Louisiana State University - Shreveport |
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Information provided by: | Louisiana State University - Shreveport |
ClinicalTrials.gov Identifier: | NCT00595582 |
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment. This study has preliminary data that indicates objective analysis of PET brain image metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).
Condition | Intervention |
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Mild Cognitive Impairment Mild Alzheimer's Disease |
Dietary Supplement: curcumin + bioperine |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Official Title: | Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine |
Estimated Enrollment: | 34 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Dietary Supplement: curcumin + bioperine
Subjects who are currently in the primary MCI study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal MCI study.
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The specific aims of this study include:
Patients diagnosed with MCI, patients who have metabolic lesions consistent with premorbid MCI, or mild AD and are currently enrolled in the primary MCI study (LSU#H04-049; NCT00243451) will be invited to participate in this clinical trial.
These subjects will be treated with 5.4 grams of curcumin per day (900 mg pills, two pills 3X/day with meals) with the inclusion of bioperine additive (formulated with the curcumin capsules) to improve bioavailability of the curcumin. Patients will be treated with curcumin/bioperine for 24 months concordant with the last two years of the three year longitudinal primary MCI study. Clinical endpoints will be change in neuropsychological scores, and size of metabolic lesions on the PET scan. Both of these measures will be recorded as part of the primary MCI study.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
MCI Inclusion Criteria (patients):
MCI criteria met:
Not demented.
MCI Exclusion Criteria (patients):
Mild Alzheimer's Disease (AD) Inclusion criteria (patients):
Cognitive impairment manifested as memory problems, problems with language, difficulty carrying out motor activities, difficulty naming things, and/or problems planning or organizing, all of which impair function and are worsening over time.
Mild Alzheimer's Disease (AD) Exclusion Criteria:
MCI Inclusion criteria (controls)
MCI Exclusion criteria (controls)
MRI findings must be normal or unremarkable for the age of the patient. Examples of abnormal (exclusory) findings are occult lacunar infarct, arteriovenous malformation) Examples of non-exclusory findings include mild atrophy, mild to moderate periventricular white matter changes. Other MRI findings will be evaluated in consultation with coinvestigator neuroradiologists and clinical judgment will be used to determine if the subject can continue in the study.
Dropout criteria (all):
Subjects that begin the study and are not able to finish the study will be tracked. Ongoing criteria for termination from the study will include:
United States, Louisiana | |
Louisiana State University Health Sciences Center | |
Shreveport, Louisiana, United States, 71103 |
Principal Investigator: | James C Patterson, MD, PhD | LSU Health Sciences Center |
Responsible Party: | LSU Health Sciences Center-Shreveport ( James C. Patterson, MD, PhD ) |
Study ID Numbers: | LSU#H05-168, LSU#H05-168 |
Study First Received: | January 4, 2008 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00595582 |
Health Authority: | United States: Institutional Review Board |
Curcumin Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Tauopathies Antirheumatic Agents Central Nervous System Agents |