Start: February 12, 2018
End: December 2023
What Is This Study About?
Valacyclovir is a drug approved by the U.S. Food & Drug Administration to treat herpes and shingles. This Phase 2 study will test the efficacy of the anti-viral drug valacyclovir (Valtrex) in treating adults with mild Alzheimer's disease who also test positive for herpes simplex virus-1 (HSV-1) or HSV-2. Participants will take four to eight coated tablets of either 500 mg of valacyclovir or placebo daily for 78 weeks. Researchers will measure amyloid accumulation on positron emission tomography (PET) scans in multiple regions of the brain, as well as changes in cognitive function and activities of daily living using assessments and tests. Investigators also will obtain measures of beta-amyloid and tau in cerebrospinal fluid from participants who agree to lumbar puncture.
Do I Qualify To Participate in This Study?
- Females must be postmenopausal (12 consecutive months without menstruation)
- Diagnosis of probable Alzheimer's disease
- Mini-Mental State Examination score 18-28
- Clinical Dementia Rating score of 1 (mild dementia)
- Study partner who is a family member or other individual who is in regular contact and can provide information on the participant
- Positive at screening for serum antibodies to HSV-1 or HSV-2 (if between positive and negative result, can be retested in six weeks)
- Use of memantine (Namenda) and cholinesterase inhibitorsdonepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne)and medications for behavioral symptoms(other than high-dose benzodiazepines) must be stable for at least two months
Must NOT have:
- Dementia other than Alzheimer's, including vascular, frontotemporal, Lewy body, and substance-induced dementia
- Modified Hachinski Scale score greater than 4
- Current diagnosis of schizophrenia, schizoaffective disorder, other psychosis, bipolar disorder, or current major depression
- Active suicidal intent or plan
- Current or recent (past six months) alcohol or substance use disorder
- Current diagnosis of other major neurological disorder, including Parkinson's disease, multiple sclerosis, central nervous system infection, Huntington's disease, and amyotrophic lateral sclerosis
- Clinical stroke with residual neurological deficits
- Acute, severe, unstable medical illness
- Cancer with active illness or metastases in the last year (past history of treated cancer allowed)
- Blood pressure level higher than 160/100 mmHg
- Kidney failure as determined by an estimated glomerular filtration rate below 44 ml/min/1.73m2
- Vitamin B12 levels below the normal range
- Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome
- Prohibited medications: benzodiazepine doses of 2 mg or more daily
- For lumbar puncture, no spinal malformation, or other reason to not undergo procedure
- For magnetic resonance imaging, no metal implants, pacemaker, or claustrophobia
- Radiation exposure in past year that, together with tracer for positron emission tomography (PET) scan, would be above limits
- Severe vision or hearing impairment that would prevent participation in psychometric tests
- Olfaction component:
- Current upper respiratory infection
- Smoke more than a pack a day
- University of Pennsylvania Smell Identification Test score of less than 12 out of 40, indicating congenital anosmia, or lifelong inability to smell
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
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?
Lead: New York State Psychiatric Institute
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03282916