Mild Cognitive ImpairmentNCT05396248
Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
A study testing Memory Retraining Exercises in people with Mild Cognitive Impairment, run by Kessler Foundation at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Memory Retraining Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jun 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 or older.
- read and speak English fluently.
- Research based diagnosis of Amnestic Mild Cognitive Impairment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Eileen Robinson, 734-763-1356, robinsoe@med.umich.edu
- Recruiting
Kessler Foundation Research Center
West Orange, New Jersey, 07052
Nancy B Moore, MA, 973-324-8450, nbmoore@kesslerfoundation.org
Nancy D Chiaravalloti, PhD, 973-324-8440, nchiaravalloti@kesslerfoundation.org
About this study
Official title: Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Memory Retraining Exercises, Placebo Control Memory Exercises
- Keywords
- Memory, learning, rehabilitation, aging, cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Retraining ExercisesBehavioural
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Placebo Control Memory ExercisesBehavioural
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions). Receives: Behavioral: Memory Retraining Exercises |
| Placebo Control Group | Placebo comparator | The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions). Receives: Behavioral: Placebo Control Memory Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal list learning
Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Participation in everyday life
Change in total score from Participation Assessment with Recombined Tools
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary outcomes (8)
Self-reported depression
Change in total score on the Geriatric Depression Scale
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported anxiety
Change in total score on the Geriatric Anxiety Scale
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported quality of life
Change in total score on the Quality of Life in Alzheimer's Disease
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported quality of well-being
Change in total score on the Quality of Well-Being Scale - Self-Administered
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Functional neuroimaging
Change in total scores from memory task during fMRI scan
Measured: two points in time: pre-treatment and immediately following treatment
Functional memory
Change in total score from Object Location Task
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Functional memory
Change in total score from the modified Everyday Memory Scenarios (EMS)
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Story memory
Change in total score from Prose Memory Test
Measured: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start28 Jun 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Michigan State University
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Nancy Chiaravalloti, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396248
- Sponsor's protocol ID
- R-1183-22
- Status last verified
- Jul 2026
- First submitted
- 18 May 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05396248
- Acronym / sponsor ID
- R-1183-22
- Conditions
- Mild Cognitive Impairment
- Keywords
- Memory, learning, rehabilitation, aging, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- University of Michigan, Michigan State University
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Memory Retraining ExercisesThe experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions). |
| Placebo Control Group | Placebo comparator | Behavioral: Placebo Control Memory ExercisesThe placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 or older.
- read and speak English fluently.
- Research based diagnosis of Amnestic Mild Cognitive Impairment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Retraining ExercisesMemory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions). | Behavioural | Experimental Group |
| Placebo Control Memory ExercisesPlacebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions). | Behavioural | Placebo Control Group |
Primary outcome
Verbal list learning
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Participation in everyday life
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Change in total score from Participation Assessment with Recombined Tools
8 secondary outcomes
Self-reported depression
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported anxiety
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported quality of life
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Self-reported quality of well-being
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Functional neuroimaging
Time frame: two points in time: pre-treatment and immediately following treatment
Functional memory
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Functional memory
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Story memory
Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Chiaravalloti principal investigator
Kessler Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Retraining Exercises in people with Mild Cognitive Impairment, run by Kessler Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Moore (1973-324-8450, nbmoore@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal list learning (time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.