Last updated: November 28, 2023
Sponsor: University of Virginia
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Memantine Hydrochloride Tablets
Placebo
Clinical Study ID
NCT05063851
HSR200202
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 to completethe 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, orwill not have fully recovered from surgery, or has major surgery planned during thetime 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
Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Memantine Hydrochloride Tablets
Phase: 2
Study Start date:
October 11, 2021
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22908
United StatesActive - Recruiting
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