NCT02087618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 6, 2014

Last Update Submit

March 13, 2014

Conditions

Mild Cognitive Impairment

Keywords

MCIAlzheimer'sDementiaTabletNon-Pharmacological InterventionCognition

Outcome Measures

Primary Outcomes (1)

  • Compliance with Kodro Solution

    Compliance with the Kodro Solution program will be assessed using: • Frequency of use (average days per week, average hours per day)

    36 weeks

Secondary Outcomes (1)

  • Satisfaction with Kodro Solution

    36-weeks

Study Arms (2)

Kodro+

ACTIVE COMPARATOR

Will begin Kodro program at baseline

Other: Kodro+

Kodro+D

PLACEBO COMPARATOR

Will begin Kodro program 12-weeks post baseline

Other: Kodro+D

Interventions

Kodro+OTHER

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

Kodro+
Kodro+DOTHER

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

Kodro+D

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ranjan Duara, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarine Salama, LMHC

CONTACT

305-674-2121Sarine.Salama@msmc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Wien Center

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

US(1)