Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI

May 13, 2025 updated by: Nancy Chiaravalloti, Kessler Foundation

Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and Mild Cognitive Impairment

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Memory enhancing techniques have been incorporated into an 8-session treatment protocol, Strategy Based Training to Enhance Memory (STEM), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants over age 60 how to restructure a memory demanding situation in order to make optimal use of the techniques.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion Criteria:

    • read and speak English fluently

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
  • Diagnosis of dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The experimental group will receive memory techniques training administered twice a week for four weeks (8 training sessions).
Behavioral: STEM
Memory technique training
Placebo Comparator: Control group
The control group will receive memory exercises administered twice a week for four weeks (8 sessions).
Behavioral: STEM
Memory technique training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Leaning task
Time Frame: Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]
Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]
Participation in Everyday life
Time Frame: Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]
Change in total score from Participation Assessment with Recombined Tools
Three points in time: pre-treatment, immediately following treatment, and 6- months after treatment is completed]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Neuroimaging
Time Frame: Two points in time: pre-treatment, immediately following treatment
Change in total scores from memory task during fMRI scan
Two points in time: pre-treatment, immediately following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-1253-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on STEM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe