Computerized Memory Enhancing Treatment in MCI

NCT05332522 | Completed

• 1 other identifier: 212375
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment

Keywords

nCCR; MCI; Mild Cognitive Impairment; Neuroplasticity-based computerized cognitive remediation

Outcome Measures

Primary Outcomes (3)

• Evaluate completion rates of nCCR

  Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment.

  2 years

• Evaluate visit frequency throughout nCCR treatment

  Assess the frequency of visits during nCCR treatment

  Through study completion, an average of 6 weeks.

• Evaluate visit duration throughout nCCR treatment

  Assess the duration of visits during nCCR treatment

  Through study completion, an average of 6 weeks.

Study Arms (1)

Neuroplasticity-based Computerized Cognitive Remediation

EXPERIMENTAL

Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation

Interventions

Neuroplasticity-based Computerized Cognitive Remediation BEHAVIORAL

The nCCR has two major components: Bottom up and Top down training. Bottom up" training: The training includes selected tasks from "Brain HQ", a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding. Top down training": We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These "Top Down" Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization.

Neuroplasticity-based Computerized Cognitive Remediation

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alexander C Conley, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Single Group Assignment A single-arm, open label design; All analyses are pre-post, with participants serving as their own controls.

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 18, 2022
• Study Start: August 9, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)