Status:
COMPLETED
Computerized Memory Enhancing Treatment in MCI
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to improve memory function in patients with Mild Cognitive Impairment (MCI).
Detailed Description
There is currently no efficacious treatment to delay or prevent decline from mild cognitive impairment (MCI) to dementia. Despite major technological advances, from refined animal models, novel molecu...
Eligibility Criteria
Inclusion
- Have a subjective memory concern as reported by participant, study partner or clinician
- Be between 55 and 85 years of age (inclusive)
- Clinical Dementia Rating16 Global score of 0.5
- Mini-Mental State Exam score between 22-30 (inclusive)
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site clinician at the time of the screening visit
- Geriatric Depression Scale score of less than or equal to 14
- Study Partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to most visits to answer questions about the participant
- Adequate visual and auditory acuity to allow neuropsychological testing
- Good general health with no additional diseases/disorders expected to interfere with the study
- Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
- Completed six grades of education or has a good work history Fluent in and able to read English.
Exclusion
- Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
- History of schizophrenia (DSM V criteria)
- History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
- Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
- Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening,
- Residence in a skilled nursing facility
- Participants whom the Principal Investigator deems to be otherwise ineligible.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05332522
Start Date
August 9 2022
End Date
December 31 2024
Last Update
February 11 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212