Computerized Cognitive Intervention in the Oldest-Old

NCT ID: NCT03397498

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-10

Study Completion Date

2014-12-16

Brief Summary

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Little is known about preventive strategies with immediate public health impact for cognitive functioning in the oldest-old (OO). Cognitive training improves cognitive functioning in the young-old (YO; 60 to 84), yet has not been examined in the OO.

Clinical trials are needed to determine if computerized cognitive training is effective at preventing or delaying cognitive decline in the OO. In order to develop such trials, information regarding use of computers and internet by the OO, and the ability and interest in such a program, must be determined.

This study will examine the effects of a computerized cognitive training program, CogniFit™, with a "classic" computerized games program, on cognitive functioning in cognitively healthy OO subjects. Information regarding use of computers and internet by the OO will be collected. Interest in and ability to complete a computerized cognitive training program will be examined, along with the cognitive, demographic, biological, and lifestyle characteristics related to this interest and ability.

Efficacy of the CogniFit™ and games programs will be assessed immediately following the training and four months after completing the training. The researchers expect that those who use the CogniFit™ program will have greater improvements than those using the games program. Finally, the participants' characteristics related to the efficacy of the programs will be examined.

Subjects recruited for this project will include those already participating in several studies of aging and cognition at the Mount Sinai School of Medicine. Recruiting from this pool of subjects will provide this program with baseline information regarding numerous subject characteristics, including cognition, family history, lifestyle, and cardiovascular information.

This study will inform future large-scale clinical trials of computerized cognitive training programs in the elderly, as well as provide information regarding the efficacy of such training in the OO. In addition, the study will identify characteristics affecting efficacy of computerized training, and thus, may suggest mechanisms through which cognitive training improves cognitive functioning in the most senior citizens of our society.

Detailed Description

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Specific Aim 1- To estimate, in cognitively normal OO, rates of 1) computer and internet use, 2) willingness to participate in a computerized cognitive training program, 3) ability to comply with the program to its completion.

Specific Aim 1a- To explore the relationships of baseline global cognition, sociodemographic, ADL/IADL, lifestyle, and biological characteristics with willingness to participate in, and with completion of a computerized cognitive training program.

Specific aim 2 - To compare the effectiveness of the CogniFit. and games programs 2 months after initiation of the intervention (corresponding to the time to complete the intervention).

Specific aim 2a - To compare the effectiveness of the CogniFit. and games programs 6 months after initiation of intervention Specific aim 3- To explore the relevance of the wide range of already available sociodemographic, lifestyle, ADL/IADL, and biological characteristics of subjects with the differential effectiveness of the programs.

Results of this study will provide essential information for planning a large-scale trial of computerized cognitive training program for the OO.

The current lack of disease modifying treatment to delay onset of slow progression to Alzheimer's disease (AD), and the robust epidemiologic evidence suggesting modifiable protective life-style factors (eg. cognitive and physical activity have led to particular interest in life-style interventions that delay the onset or slow the progression of cognitive decline.

Conditions

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Cognition Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Participants are not told which group they are assigned to, and the investigator (PI) and coordinators completing the cognitive evaluation are not told which group the participants are assigned to.

Study Groups

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Computerized cognitive training

Received the Computerized cognitive training program, CogniFit™

Group Type EXPERIMENTAL

CogniFit™

Intervention Type BEHAVIORAL

The program utilizes 21 tasks, which may develop 14 cognitive domains: awareness, inhibition, spatial perception, visual short term memory, working memory, hand-eye coordination, visual scanning, response time, divided attention, time estimation, visual perception, shifting, naming, and planning.

Control-games

Received the Computerized games program

Group Type ACTIVE_COMPARATOR

Control-games

Intervention Type BEHAVIORAL

The program utilizes classic computer games, which may develop cognitive domains. Games will be used over 8 weeks. The participants will use the program 3 days a week, with one rest day between each session. Each session lasts approximately 20 minutes. The participant will use the program for a total number of 24 sessions.

Interventions

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CogniFit™

The program utilizes 21 tasks, which may develop 14 cognitive domains: awareness, inhibition, spatial perception, visual short term memory, working memory, hand-eye coordination, visual scanning, response time, divided attention, time estimation, visual perception, shifting, naming, and planning.

Intervention Type BEHAVIORAL

Control-games

The program utilizes classic computer games, which may develop cognitive domains. Games will be used over 8 weeks. The participants will use the program 3 days a week, with one rest day between each session. Each session lasts approximately 20 minutes. The participant will use the program for a total number of 24 sessions.

Intervention Type BEHAVIORAL

Other Intervention Names

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Computerized cognitive training program Computerized games program

Eligibility Criteria

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Inclusion Criteria

* Age 80+
* Normal cognition by consensus conference, MMSE\> 25th percentile norm, CDR=0
* Has computer with internet access that is capable of running the computerized cognitive training program.
* Willing to dedicate the necessary time to the project

Exclusion Criteria

* Prior or current participation in another cognitive intervention study
* Medical disease that precludes consistent participation or that affects cognition
* Poor vision
* Poor hearing
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Schnaider-Beeri, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Jewish Home Lifecare

New York, New York, United States

Site Status

Icahn School of Medicine at Mount Sinia

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 09-2339

Identifier Type: -

Identifier Source: org_study_id

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