Computerized Cognitive Intervention in the Oldest-Old

Dementia Clinical Trial

Official title: Computerized Cognitive Intervention in the Oldest-Old: A Feasibility Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cognition
• Dementia

• NCT number: NCT03397498
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: N/A
• Start date: March 10, 2011
• Completion date: December 16, 2014