Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment

NCT04533204

Mild Cognitive Impairment

COMPLETED NA

Improving New Learning and Memory in Traumatic Brain Injury

NCT01207375

Traumatic Brain Injury

COMPLETED NA

Exercise Training to Improve Cognitive Function

NCT03824639

Mild Cognitive Impairment

COMPLETED NA

Application of the Modified Story Memory Technique (mSMT)© to Aging

NCT03370224

Aging Mild Cognitive Impairment

ENROLLING_BY_INVITATION NA

Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

NCT03983681

Multiple Sclerosis

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).

Group Type EXPERIMENTAL

Memory Retraining Exercises

Intervention Type BEHAVIORAL

Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Placebo Control Group

The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).

Group Type PLACEBO_COMPARATOR

Placebo Control Memory Exercises

Intervention Type BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Memory Retraining Exercises

Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Intervention Type BEHAVIORAL

Placebo Control Memory Exercises

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 60 or older.
* read and speak English fluently.
* Research based diagnosis of Amnestic Mild Cognitive Impairment

Exclusion Criteria

* prior stroke or neurological injury/disease (i.e. traumatic brain injury, Multiple Sclerosis, or Stroke).
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
* significant alcohol or drug abuse history (inpatient treatment).
* Benzodiazepines and steroid use

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No