Phase
Condition
N/ATreatment
Memantine Hydrochloride Tablets
Placebo
Clinical Study ID
Ages 50-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be between the age of 50 and 65 years at time of informed consent.
Have a positive family history for dementia (minimum of 1 first degree relative).
Previously known or documented heterozygote or homozygote ApoE ε4 allele.
Be able to read and write and must have adequate hearing and visual acuity tocomplete the psychometric tests.
Be otherwise healthy for their age group or medically stable with or withoutmedication on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or at baseline.
Have Montreal Cognitive Assessment (MOCA) score of 27 or above.
Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula,greater or equal to 30 mL/minute.
Exclusion
Exclusion Criteria:
A current clinical condition or requires a medication that raises the pH of theirurine.
Severe renal or hepatic impairment.
Any other abnormality that could cause a possible cognitive deficit (including, butnot limited to, vascular encephalopathy or large strokes).
Contraindications for MRI (e.g., prostheses, implants, claustrophobia, pacemaker) orPET imaging.
Neurodegenerative disorder known to cause neurocognitive decline
Relevant history of or current neurological disease other than preclinical AD, whichmay make interpretation of possible new neurological signs or symptoms difficult.
Clinically significant and active pulmonary, gastrointestinal, renal, hepatic,endocrine, or cardiovascular system disease
Ongoing cancer treatment
Clinically significant and active psychiatric disorder
Use of an investigational medical device within 3 months before the planned start ofstudy.
Current participation in an interventional study with an investigational drugcomponent.
Major surgery (e.g., requiring general anesthesia) within 8 weeks before screening,or will not have fully recovered from surgery, or has major surgery planned duringthe time the subject is expected to participate in the study.
Requires treatment with an AChE inhibitor or any of the following: acetazolamide,methazolamide, amantadine, ketamine, dextromethorphan.
Study Design
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available

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