Computerized Cognitive Training for the Elderly

Aging Clinical Trial

Official title:

Computerized Cognitive Training for the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02632604
• Other study ID #: 110.180/2013
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2015
• Last updated: January 12, 2018
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Universidade Federal do Rio de Janeiro
• Contact: Rogério Panizzutti, M.D, PhD
• Phone: +552139386390
• Email: rogerio[@]icb.ufrj.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly

Description:

Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.

The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.

The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.

The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;

Exclusion Criteria:

• Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Computerized cognitive training
40 hours of a computerized cognitive training, given 1 hour daily
• Computer games

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global cognition score change	An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline	through study completion, an average of 1 year
Secondary	Processing speed score change	Processing speed score will be measured using the identification task from Cogstate tests battery	through study completion, an average of 1 year
Secondary	Attention score change	Attention score will be measured using the detection task from Cogstate tests battery	through study completion, an average of 1 year
Secondary	Concentration score change	Concentration score will be measured using the Trail Making Test	through study completion, an average of 1 year
Secondary	Short-term memory score change	Short- term memory score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
Secondary	long-term memory score change	long- term memory score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
Secondary	learning score change	learning score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
Secondary	working memory score change	working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery	through study completion, an average of 1 year
Secondary	Semantic memory score change	semantic memory score will be measured using the Verbal fluency test	through study completion, an average of 1 year
Secondary	Cognitive flexibility score change	Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery	through study completion, an average of 1 year
Secondary	social cognition score change	Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery	through study completion, an average of 1 year
Secondary	Depression score change	Depression score will be measured using the Geriatric Depression Scale	through study completion, an average of 1 year
Secondary	Instrumental activity of daily living score change	Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale	through study completion, an average of 1 year
Secondary	Independence in activities of daily living score change	Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale	through study completion, an average of 1 year
Secondary	Functional status score change	Functional status score will be measured using the Direct Assessment of Functional Status questionnaire	through study completion, an average of 1 year
Secondary	Timed instrumental activities of daily living score change	Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale	through study completion, an average of 1 year
Secondary	Physical activity score change	Physical activity score will be measured using the International Physical Activity Questionnaire	through study completion, an average of 1 year
Secondary	Praxis score change	Praxis score will be measured using the Cambridge Cognition Examination test	through study completion, an average of 1 year
Secondary	Episodic memory score change	Episodic memory score will be measured using the Cambridge Cognition Examination test	through study completion, an average of 1 year
Secondary	Quality of life score change	Quality of life will be assessed with the World Health Organization Quality of Life questionnaire	through study completion, an average of 1 year