Computerized Cognitive Intervention in the Oldest-Old

NCT03397498 | Completed

• 1 other identifier: GCO 09-2339
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cognition; Dementia

Keywords

computerized cognitive training

Outcome Measures

Primary Outcomes (1)

• Change in Global Cognition Composite

  Memory, Immediate recall; Word List Memory, Delayed recall; Word List Memory, Recognition; Logical Memory Story A, Immediate recall; Logical Memory Story A, Delayed recall; Logical Memory Story A, Recognition, Target Cancellation Tests (diamond and TMX); Trail Making Test (Parts A and B); Digit Symbol Substitution Test; Digit Span tests (Forward and Backward), Similarities; Boston Naming Test; and Category Fluency and Letter Fluency tests at completion of program as compared to baseline.

  Baseline and after completion of program (approximately 7-8 weeks)

Secondary Outcomes (4)

• Change in Memory Function

  Baseline and after completion of program (approximately 7-8 weeks)

• Change in Logical Memory Story A

  Baseline and after completion of program (approximately 7-8 weeks)

• Change in Attention/Executive function score

  Baseline and after completion of program (approximately 7-8 weeks)

• Change in Language function score

  Baseline and after completion of program (approximately 7-8 weeks)

Study Arms (2)

Computerized cognitive training

EXPERIMENTAL

Received the Computerized cognitive training program, CogniFit™

Behavioral: CogniFit™

Control-games

ACTIVE COMPARATOR

Received the Computerized games program

Behavioral: Control-games

Interventions

CogniFit™ 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.

Also known as: Computerized cognitive training program

Computerized cognitive training

Control-games 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.

Also known as: Computerized games program

Control-games

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior or current participation in another cognitive intervention study
• Medical disease that precludes consistent participation or that affects cognition
• Poor vision
• Poor hearing

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Jewish Home Lifecare

New York, New York, 10025, United States

Location

Icahn School of Medicine at Mount Sinia

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michal Schnaider-Beeri, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 12, 2018
• Study Start: March 10, 2011
• Primary Completion: December 16, 2014
• Study Completion: December 16, 2014
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (2)