Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT01383161
Eligibility Criteria:
Inclusion Criteria
1. Agreement to participate in the 18-month double-blind, placebo-controlled clinical trial of curcumin.
2. Diagnostic criteria for mild cognitive impairment (MCI) or any age related memory decline according to standard criteria (Petersen et al, 2001; Crook et al, 1986).
3. Age 50 to 90 years.
4. No significant cerebrovascular disease: modified Ischemic Score of \< 4 (Rosen et al, 1980).
5. Adequate visual and auditory acuity to allow neuropsychological testing.
6. Screening laboratory tests and EKG without significant abnormalities that might interfere with the study.
Exclusion Criteria
1. Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984).
2. Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
3. Inability to undergo MRI.
4. Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
5. History of myocardial infarction within the previous year, or unstable cardiac disease.
6. Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100).
7. History of significant liver disease, clinically-significant pulmonary disease, diabetes, or cancer.
8. Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
9. Current diagnosis or history of alcoholism or substance addiction.
10. Regular use of any medication that may affect cognitive functioning including: centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
11. Use of more than one multivitamin per day. Vitamins other than the standard multivitamin supplement will not be allowed.
12. Use of medications known to affect FDDNP-PET binding (e.g., ibuprofen, naproxen).
13. Use of more than one daily baby aspirin (81mg) and/or use of any medication containing curcumin.
14. Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
15. Use of any investigational drugs within the previous month or longer, depending on drug half-life.
16. Pregnancy.
17. HIV infection.
18. Evidence of vasogenic edema; specifically, evidence of more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite") or a single area of superficial siderosis), or evidence of a prior macrohemorrhage at screening or baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01383161
Study Brief:
Protocol Section:
NCT01383161