Clinical trial NCT03397498: Computerized Cognitive Intervention in the Oldest-Old
Official title: Computerized Cognitive Intervention in the Oldest-Old: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Dementia
Keywords: computerized cognitive training
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 69
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Global Cognition Composite
timeFrame: Baseline and after completion of program (approximately 7-8 weeks)
Secondary outcomes:
measure: Change in Memory Function
timeFrame: Baseline and after completion of program (approximately 7-8 weeks)
measure: Change in Logical Memory Story A
timeFrame: Baseline and after completion of program (approximately 7-8 weeks)
measure: Change in Attention/Executive function score
timeFrame: Baseline and after completion of program (approximately 7-8 weeks)
measure: Change in Language function score
timeFrame: Baseline and after completion of program (approximately 7-8 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Jewish Home Lifecare
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinia
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Michal Schnaider-Beeri, PhD
role: PRINCIPAL_INVESTIGATOR
References: