NCT05396248 Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
| NCT ID | NCT05396248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-06-28 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Nancy Chiaravalloti
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT05396248 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05396248 currently recruiting?
Yes, NCT05396248 is actively recruiting participants. Contact the research team at nbmoore@kesslerfoundation.org for enrollment information.
Where is the NCT05396248 trial being conducted?
This trial is being conducted at Ann Arbor, United States, West Orange, United States.
Who is sponsoring the NCT05396248 clinical trial?
NCT05396248 is sponsored by Kessler Foundation. The principal investigator is Nancy Chiaravalloti at Kessler Foundation. The trial plans to enroll 120 participants.