Start:
May 2014
End:
June 2021
Enrollment:
150
What Is This Study About?
This study will determine whether taking an omega 3 polyunsaturated fatty acid (fish oil) can promote brain health in cognitively normal older adults at risk for dementia.
Do I Qualify To Participate in This Study?
Must have:
- Cognitively normal (Clinical Dementia Rating [CDR] = 0 or 0.5)
- Total white matter hyperintensity volume of 6 cc or less
- Plasma polyunsaturated fatty acid level of less than 110 ug/ml or less than 5 weight percent
- Sufficient English language skills to complete all tests
- Geriatric Depression Scale score showing absence of significant depression
- Sufficient vision and hearing to complete all tests
- Study partner with frequent (at least 1 hour/day or 1 day/week) contact with subject to verify functional status and CDR rating
Must NOT have:
- Any dementing illness such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus, or Parkinson's disease (CDR ≥ 1)
- Significant central nervous system disease such as brain tumor, seizure disorder, subdural hematoma, or cranial arteritis
- Alcohol or substance abuse within the last 2 years
- Major depression, schizophrenia, or other major psychiatric disorder
- Abnormal laboratory results indicating vitamin B12 deficiency, thyroid disease, or urinary tract infection
- Unstable or significantly symptomatic cardiovascular disease
- Hypertension, as indicated by either blood pressure of 150/90 or more or medications to control blood pressure
- Symptomatic orthostatic hypotension
- Diabetes mellitus requiring insulin injections
- History of cortical stroke
- Cancer within the last 5 years, with the exception of localized prostate cancer nonmetastatic skin cancers
- Illness that requires more than one visit /month to a clinician
- Progressive vision loss (age-related macular degeneration already beginning to degrade vision)
- Contraindications to MRI, including heart pacemaker, metal plates or objects in head, metal worker
- Prohibited medications: frequent high doses of analgesics; sedatives, except occasionally for sleep (use limited to twice per week); central nervous system medications not at stable doses for at least 2 months (cimetidine, beta-blockers, and SSRIs); more than two antihypertensives or propranolol or clonidine; neuroleptics, antiparkinsonian agents, systemic corticosteroids, or narcotic analgesics; omega 3 polyunsaturated fatty acid supplements; cholinesterase inhibitors; anticoagulation therapy such as vitamin K agonist, warfarin, Factor X inhibitors, or low molecular weight heparins
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Source:
ClinicalTrials.gov ID:
NCT01953705