Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The use of memantine for prevention of Alzheimer's Disease (AD) is designed to assess the feasibility of the use of memantine hydrochloride for prevention of AD and provide design elements for a Phase 3 efficacy study. Up to 128 subjects will be enrolled/screened to achieve a sample size of 32 randomized participants with a 1:1 randomization allocation. The study population will include individuals, 57-62 years of age, who are APOE4 positive with a family history of Alzheimer's Disease who meet all other eligibility criteria. The schedule of assessments includes screening/baseline, treatment period (including titration up/down) and follow up/end of study over 101 weeks for each subject. Study efficacy assessments are the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Montreal Cognitive Assessment (MoCA), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL), Cognitive Function Index, Alzheimer's Disease Cooperative Study - Activities of Daily Living Prevention Instrument Activities of Daily Living - Prevention Instrument and the Clinical Dementia Rating Scale (CDR) Scale. Safety assessments include the Center for Epidemiologic Studies Depression Scale (CES-D) Vital Signs, Physical/Neurological Exam, Electrocardiogram, Blood Chemistries, Urinalysis, Medical History, Assessment of Adverse Events and Concomitant Medications, MRI and PET imaging. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063851
Study type Interventional
Source University of Virginia
Contact Amy Fansler
Phone 434-243-1760
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Active, not recruiting NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Recruiting NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Recruiting NCT04149860 - Study With Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease Phase 1
Withdrawn NCT02707978 - F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD) Phase 2
Not yet recruiting NCT03208491 - [email protected]: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders N/A
Recruiting NCT04604600 - Multimodal Biomarkers for Diagnosis and Prognosis in VCI Phase 3
Recruiting NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Enrolling by invitation NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT04488419 - ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease Phase 2
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Recruiting NCT03671889 - ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease N/A
Recruiting NCT03056495 - Clinical Trial to Determine Tolerable Dosis of Vorinostat in Patients With Mild Alzheimer Disease Phase 1