ACTIVE_NOT_RECRUITING

The Use of Memantine for Prevention of Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

As the US population ages, the prevalence of dementia is increasing, and Alzheimer's Disease (AD) is the most prevalent one. Solving the Alzheimer's Disease (AD) epidemic is likely to require preventive therapy beginning many years before symptoms are expected to be evident in at-risk individuals. AD is caused by the dysfunction, loss of synapses, and eventual neuronal death, which may occur up to 25 years before clinical symptoms appear. This study, based off of pre-clinical data, seeks to assess whether it is feasible to use memantine hydrochloride for the prevention of Alzheimer's Disease.

Official Title

The Use of Memantine for Prevention of Alzheimer's Disease

Quick Facts

Study Start:2021-10-11

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05063851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be between the age of 50 and 65 years at time of informed consent. 2. Have a positive family history for dementia (minimum of 1 first degree relative). 3. Previously known or documented heterozygote or homozygote ApoE ε4 allele. 4. Be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests. 5. Be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or at baseline. 6. Have Montreal Cognitive Assessment (MOCA) score of 27 or above. 7. Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula, greater or equal to 30 mL/minute.	1. A current clinical condition or requires a medication that raises the pH of their urine. 2. Severe renal or hepatic impairment. 3. Any other abnormality that could cause a possible cognitive deficit (including, but not limited to, vascular encephalopathy or large strokes). 4. Contraindications for MRI (e.g., prostheses, implants, claustrophobia, pacemaker) or PET imaging. 5. Neurodegenerative disorder known to cause neurocognitive decline 6. Relevant history of or current neurological disease other than preclinical AD, which may make interpretation of possible new neurological signs or symptoms difficult. 7. Clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease 8. Ongoing cancer treatment 9. Clinically significant and active psychiatric disorder 10. Use of an investigational medical device within 3 months before the planned start of study. 11. Current participation in an interventional study with an investigational drug component. 12. 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 during the time the subject is expected to participate in the study. 13. Requires treatment with an AChE inhibitor or any of the following: acetazolamide, methazolamide, amantadine, ketamine, dextromethorphan.

Inclusion Criteria

Exclusion Criteria

1. Be between the age of 50 and 65 years at time of informed consent.
2. Have a positive family history for dementia (minimum of 1 first degree relative).
3. Previously known or documented heterozygote or homozygote ApoE ε4 allele.
4. Be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests.
5. Be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or at baseline.
6. Have Montreal Cognitive Assessment (MOCA) score of 27 or above.
7. Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula, greater or equal to 30 mL/minute.

1. A current clinical condition or requires a medication that raises the pH of their urine.
2. Severe renal or hepatic impairment.
3. Any other abnormality that could cause a possible cognitive deficit (including, but not limited to, vascular encephalopathy or large strokes).
4. Contraindications for MRI (e.g., prostheses, implants, claustrophobia, pacemaker) or PET imaging.
5. Neurodegenerative disorder known to cause neurocognitive decline
6. Relevant history of or current neurological disease other than preclinical AD, which may make interpretation of possible new neurological signs or symptoms difficult.
7. Clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease
8. Ongoing cancer treatment
9. Clinically significant and active psychiatric disorder
10. Use of an investigational medical device within 3 months before the planned start of study.
11. Current participation in an interventional study with an investigational drug component.
12. 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 during the time the subject is expected to participate in the study.
13. Requires treatment with an AChE inhibitor or any of the following: acetazolamide, methazolamide, amantadine, ketamine, dextromethorphan.

Contacts and Locations

Principal Investigator

Carol Manning, PhD

PRINCIPAL_INVESTIGATOR

Professor of Neurology

Anelyssa D'Abreu, MD

PRINCIPAL_INVESTIGATOR

Associate Professor of Neurology

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Carol Manning, PhD, PRINCIPAL_INVESTIGATOR, Professor of Neurology
Anelyssa D'Abreu, MD, PRINCIPAL_INVESTIGATOR, Associate Professor of Neurology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11

Study Completion Date2026-12

Study Record Updates

Study Start Date2021-10-11

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease