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Kodro+ for Mild Cognitive Impairment (KodroSol Trial)

N/A
Waitlist Available
Led By Ranjan Duara, MD
Research Sponsored by Mt. Sinai Medical Center, Miami
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 36-weeks
Awards & highlights

KodroSol Trial Summary

This is a pilot study to examine the feasibility of a formal 30-minute daily program on a tablet computer (simply a "tablet") in subjects with mild cognitive impairment (MCI). The purpose of the program, known as Kodro Solution, is to increase physical activity, maintain social interaction, improve nutrition and exercise cognitive skills using a tablet. In addition to feasibility, outcome measures will include: (a) health-related quality of life, (b) self-esteem, (c) activities of daily living, (d) socialization, (e) mood, and (f) cognition. Study participants must have a study partner who can assist them with training on use of the tablet and the Kodro Solution program. Fifty (50) study subjects and their study partners will be recruited at the Wien Center. A delayed start design will be utilized. Study subjects will be randomly assigned to either active treatment (Kodro+) or delayed treatment (Kodro+D). Active treatment with Kodro Solution will be initiated at the baseline visit for Kodro+ subjects and 12 weeks after baseline for Kodro+D subjects. The 12-week period without tablets will serve as a control. Active treatment with Kodro Solution will continue for 36 weeks for the Kodro+ subjects and 24 weeks for the Kodro+D subjects. For both groups, the outcome measures will be assessed at baseline, week 12 and week 36. The lagged design will facilitate enrollment and enable the assessment of a dose effect.

Eligible Conditions
  • Mild Cognitive Impairment

KodroSol Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance with Kodro Solution
Secondary outcome measures
Satisfaction with Kodro Solution

KodroSol Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Kodro+Active Control1 Intervention
Will begin Kodro program at baseline
Group II: Kodro+DPlacebo Group1 Intervention
Will begin Kodro program 12-weeks post baseline

Find a Location

Who is running the clinical trial?

Mt. Sinai Medical Center, MiamiLead Sponsor
18 Previous Clinical Trials
4,040 Total Patients Enrolled
Kodro Inc.Industry Sponsor
Ranjan Duara, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

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~5 spots leftby Apr 2025