What is the mechanism of action of this treatment?

The DEMA intervention for Mild Cognitive Impairment (MCI) focuses on engaging patients in meaningful activities and providing self-management education. The mechanisms of action include cognitive stimulation through activities that are personally significant, which can enhance neuroplasticity and cognitive reserve. Additionally, self-management education empowers patients by improving their understanding of MCI and teaching strategies to cope with cognitive challenges. These approaches can lead to improved life satisfaction, better health outcomes, and potentially slow the progression of cognitive decline by maintaining mental and emotional engagement.

What side effects are associated with this type of intervention?

Non-pharmacological treatments for Mild Cognitive Impairment (MCI), such as those involving engagement in meaningful activities and self-management education, generally have minimal side effects. These interventions aim to improve life satisfaction and health outcomes without significant adverse effects. However, some patients may experience initial frustration or anxiety when adapting to new routines or activities. In contrast, pharmacological treatments for MCI, such as cholinesterase inhibitors, can cause gastrointestinal issues, dizziness, and headaches. It is essential to monitor patients closely to balance the benefits and potential side effects of any treatment.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of Mild Cognitive Impairment (MCI). However, non-pharmacological interventions like the Daily Engagement in Meaningful Activities (DEMA) are being studied for their potential benefits. These interventions focus on improving life satisfaction and health outcomes through engagement in meaningful activities and self-management education. While pharmacological treatments for Alzheimer's disease, such as cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), are sometimes used off-label for MCI, their efficacy in this population remains uncertain.

What other types of research exist?

Promising, novel alternatives to DEMA for MCI patients include: 1) 'My Healthy Brain' program, which uses a group-based lifestyle approach delivered via live video to target multiple risk factors for dementia, including diet, physical activity, and sleep. 2) Nonpharmacological interventions such as tailored light therapy to improve circadian rhythms and sleep quality. 3) Multidomain lifestyle interventions that combine physical exercise, cognitive training, and social engagement to enhance cognitive and psychosocial outcomes.

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DEMA Intervention for Mild Cognitive Impairment (PRIMA Trial)

N/A

Recruiting

Led By Yvonne Y Lu, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline life satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

Awards & highlights

Summary

This trial is testing whether the DEMA intervention can improve life satisfaction and health outcomes for patients and caregivers, compared to the attention control group.

Who is the study for?

This trial is for pairs of adults over 59 with mild cognitive impairment (MCI) and their caregivers. Participants need to speak English, be oriented in time and space, have a phone, and not require help with daily tasks. Caregivers must be adults providing unpaid care without severe cognitive issues themselves.Check my eligibility

What is being tested?

The study tests the DEMA program against an information support group. DEMA aims to improve life satisfaction by helping patients/caregivers identify meaningful activities and learn about MCI through sessions with a nurse.See study design

What are the potential side effects?

Since this intervention involves educational activities rather than medication, typical drug side effects are not expected. However, participants may experience emotional or psychological responses to discussing MCI-related topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-consent for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Life satisfaction

Secondary outcome measures

Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]

Caregiving Outcomes Scale (COS)

Patient Health Questionnaire-9 Items (PHQ-9)

+2 more

Other outcome measures

Confidence Scale

Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions)

Demographic Profile and Comorbidity Condition

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Daily Engagement Meaningful Activity (DEMA)Experimental Treatment1 Intervention

This group will receive 7 individualized sessions, 1 face-to-face session at week 1 and via 6 bi weekly telephone sessions delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.

Group II: Information Support (IS)Placebo Group1 Intervention

This group will attend 1 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer disease educational brochure from the Alzheimer's Association (AA). The face-to-face sessions will take place at the IADC Clinical Core clinic, Indiana University Center of Excellence of Women's Health clinic, or Indiana School of Nursing conference room that based on patient-caregiver dyad's preference. Then they will receive 6 bi weekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The DEMA intervention for Mild Cognitive Impairment (MCI) focuses on engaging patients in meaningful activities and providing self-management education. The mechanisms of action include cognitive stimulation through activities that are personally significant, which can enhance neuroplasticity and cognitive reserve. Additionally, self-management education empowers patients by improving their understanding of MCI and teaching strategies to cope with cognitive challenges. These approaches can lead to improved life satisfaction, better health outcomes, and potentially slow the progression of cognitive decline by maintaining mental and emotional engagement.

The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) - study protocol of a cluster-randomised controlled trial.Helping persons with mild or moderate Alzheimer's disease recapture basic daily activities through the use of an instruction strategy.

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Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

588 Previous Clinical Trials

10,379,581 Total Patients Enrolled

Indiana UniversityLead Sponsor

997 Previous Clinical Trials

1,095,194 Total Patients Enrolled

Yvonne Y Lu, PhDPrincipal InvestigatorIndiana University School of Medicine

Media Library

Daily Engagement Meaningful Activity (DEMA) Clinical Trial Eligibility Overview. Trial Name: NCT04515875 — N/A

Mild Cognitive Impairment Research Study Groups: Information Support (IS), Daily Engagement Meaningful Activity (DEMA)

Mild Cognitive Impairment Clinical Trial 2023: Daily Engagement Meaningful Activity (DEMA) Highlights & Side Effects. Trial Name: NCT04515875 — N/A

Daily Engagement Meaningful Activity (DEMA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515875 — N/A

~105 spots leftby Jun 2025

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