Start:
January 2014
End:
May 2018
Enrollment:
212
What Is This Study About?
This study will examine whether drinking pomegranate juice daily for 1 year will benefit cognitive abilities in middle-aged and older adults without dementia. Researchers predict that participants who drink pomegranate juice will show better cognitive performance than those who drink a placebo.
Do I Qualify To Participate in This Study?
Must have:
- Normal cognition or mild cognitive impairment
- Adequate seeing and hearing ability to allow neuropsychological testing
- Screening laboratory tests and EKG without significant abnormalities that might interfere with the study; if tests show abnormalities, subject must obtain written clearance from primary care physician
Must NOT have:
- Diagnosis of probable Alzheimer's disease or any other dementia
- Evidence of other neurological or physical illness that can produce cognitive deterioration
- History of stroke, transient ischemic attack, carotid bruits, or lacunes seen on MRI scan
- Contraindication to MRI, including claustrophobia, metal in body, surgery within past 60 days, certain implants, or previous abnormal MRI results
- Evidence of Parkinson's disease
- History of myocardial infarction within the past year or unstable cardiac disease
- Uncontrolled hypertension (systolic blood pressure > 170 mm Hg or diastolic blood pressure > 100 mm Hg)
- History of significant liver disease, clinically significant pulmonary disease, or diabetes
- Current diagnosis of any major psychiatric disorder
- Current diagnosis or history of alcoholism or substance addiction
- Pregnancy
- Regular use of any medication that may affect cognitive functioning, including: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, antipsychotics, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anticonvulsants, or warfarin
- Occasional use of anxiety or sleeping medications known to cause cognitive dulling will be allowed but discouraged: chloral hydrate; non-benzodiazepine hypnotics such as Ambien (zolpidem) or Lunesta (eszopiclone); benzodiazepines such as Ativan (lorazepam), Xanax (alprazolam), Klonopin (clonazepam), and Restoril (temazepam)
- Other prohibited medications: amitriptyline, amiodarone, desipramine, fenofibrate, flecainide, fluconazole, fluoxetine, fluvastatin, fluvoxamine, isoniazid, lovastatin, ondansetron, phenylbutazone, probenecid, sertraline, sulfamethoxazole, sulfaphenazole, teniposide, voriconazole, and zafirlukast; supplements such as ginkgo biloba or anything containing pomegranate or pomegranate juice
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?
Collaborator Sponsor
Source:
ClinicalTrials.gov ID:
NCT02093130