Recruiting

Tablet-based Intervention

Sponsor:

Mt. Sinai Medical Center, Miami

Code:

NCT02087618

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Kodro+

Kodro+D

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment

Study ID

NCT02087618

Start date

Mar, 2014

Status verified date

Mar, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of Mild Cognitive Impairment as defined below:
  • Clinical Dementia Rating (CDR) global score = 0.5 (Morris 1993)
  • MMSE > 20
  • Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised (DSM-IV-TR) criteria of dementia not fulfilled (Appendix II)
  • 60 years and older
  • Subjective memory complaints
  • Able to use Kodro by him/her self or with minimal assistance from the study partner
  • Understands English at an 8th grade proficiency level
  • Wifi access in the subject's home
  • Willing and able to connect to Kodro for a minimum of 30 minutes daily
  • Study partner able to fill in the self-report questionnaires during visits and supervise the subject as needed

Exclusion Criteria:

  • MMSE < 20
  • Motor or sensory disorders limiting the manipulation of an tablet
  • Any involvement with brain-based programs during the study (e.g., Posit Science, Luminosity)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Kodro+

Will begin Kodro program at baseline

placebo comparator: Kodro+D

Will begin Kodro program 12-weeks post baseline

Interventions

Kodro+

Kodro+ participants will utilize Kodro Solution on a tablet for 30 minutes a day for 36 weeks

Kodro+D

Kodro+D participants will utilize the Kodro Solution program 12-weeks post-baseline for 30 minutes per day for 24-weeks

Primary outcome measure

  • Compliance with Kodro Solution [ Time Frame: 36 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

Ranjan Duara, MD

More Information

Sponsor

Mt. Sinai Medical Center, Miami

Last update posted

Mar 14, 2014

Last verified

Mar, 2014

Keywords

  • MCI
  • Alzheimer's
  • Dementia
  • Tablet
  • Non-Pharmacological Intervention
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mt. Sinai Medical Center, Miami on 2014-03-14.