NCT02388451

Brief Summary

15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

February 26, 2015

Last Update Submit

January 20, 2019

Conditions

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Mindstreams Mild Cognitive Impairment Computerized Assessment Battery

    The Mindstreams Mild Cognitive Impairment Computerized Assessment Battery developed by Neurotrax Corp. provides index scores in multiple cognitive domains, as well as a Global cognitive score

    Change from Baseline Cognitive Function at 15 weeks

Study Arms (1)

Feuerstein Program

EXPERIMENTAL

15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.

Device: Feuerstein Program

Interventions

The IE activity is administered by instructors in groups of 10 to 15 participants. The intervention comprises 30 twice weekly meetings of 90 minutes duration per group.

Feuerstein Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years and older
  • Able to read and speak Hebrew
  • Provide informed consent for participation in the study
  • Clinical diagnosis of MCI based on Consensus Criteria
  • A score of lower than 95 on the Memory Index of the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery

You may not qualify if:

  • A medical condition (such as advanced heart failure, unstable ischemic heart disease, a lung condition with dyspnea on mild effort, intractable pain) or functional impairment (especially limiting mobility without the home) that does not allow the subject to participate in the training activities for the full duration of the study
  • A diagnosis of depression, bipolar disorder or schizophrenia
  • A cognitive diagnosis other than MCI, such as delirium, dementia or mental retardation
  • Visual impairment not corrected by the use of spectacles
  • Hearing impairment not corrected by hearing aids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan Press

Beersheba, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 17, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2017

Study Completion

August 1, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations