CompletedNot Applicable

Computerized Memory Enhancing Treatment in MCI

United States19 participantsStarted 2022-08-09

Plain-language summary

The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to improve memory function in patients with Mild Cognitive Impairment (MCI).

Who can participate

Age range55 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Evaluate completion rates of nCCR

Timeframe: 2 years

Evaluate visit frequency throughout nCCR treatment

Timeframe: Through study completion, an average of 6 weeks.

Evaluate visit duration throughout nCCR treatment

Timeframe: Through study completion, an average of 6 weeks.

Trial details

NCT IDNCT05332522

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Mild Cognitive Impairment trials