Start: November 27, 2020
End: February 2026
What Is This Study About?
This phase 2 trial will assess the effects of an existing drug, leuprolide acetate (Eligard), in women with Mild Cognitive Impairment or Alzheimer's disease who take a stable dose of donepezil (Aricept). Participants will be randomly assigned to take either the study drug or a placebo as an injection given once every 12 weeks for 48 weeks (total of four injections). Researchers will measure cognitive function and overall function, as well as plasma and neuroimaging biomarkers of Alzheimer's by MRI.
Do I Qualify To Participate in This Study?
- Probable Alzheimer's disease, or Mild Cognitive Impairment due to Alzheimer's disease, at screening visit
- MoCA score of more than 11 or a blind MoCA score greater than 8
- Hachinski score <5 supporting clinical judgment that dementia is not of vascular origin
- Taking a stable dose of donepezil (Aricept) for at least 90 days, and dosage likely to remain stable throughout the trial
- Fluent in English
- Living at home or in a facility other than a nursing home with a caregiver who sees the patient at least three times a week for a total of at least 10 hours and can sign the consent form, accompany the patient on clinic visits, and participate in evaluations
Must NOT have:
- Significant brain disease other than Alzheimer's, such as schizophrenia, epilepsy, Parkinson's disease, or stroke
- Current substance abuse
- Significant depression
- Physical or psychological magnetic resonance imaging (MRI) contraindications or likely unable to tolerate neuroimaging
- Prohibited medications: memantine (Namenda); other medications known to affect serum sex hormone or gonadotropin concentrations, such as estrogen and/or progesterone for hormone replacement therapy, goserelin, or danazol
- Significant systemic illness likely to interfere with participation or completion of study or to affect study results, such as cancer within past 5 years (other than nonmelanoma skin cancer), autoimmune disease, recent myocardial infarction, signs/symptoms of organ failure based on history, ECG, screening laboratory and/or physical exams
- Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer
- Ever treated with active or passive immunization as part of a different clinical trial for Alzheimer's
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Tom Maloney, PhD
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: Weill Medical College of Cornell University
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03649724