- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269939
Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI
July 21, 2026 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
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
- Name: Nancy Moore
- Phone Number: 19733248450
- Email: nbmoore@kesslerfoundation.org
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Nancy Moore
- Phone Number: 973-324-8450
- Email: nbmoore@kesslerfoundation.org
-
-
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).
|
Memory technique training
|
|
Placebo Comparator: Control group
The control group will receive memory exercises administered twice a week for four weeks (8 sessions).
|
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
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 (Actual)
December 15, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2027
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)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.