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CognitionNCT03397498

Computerized Cognitive Intervention in the Oldest-Old

A study testing CogniFit™ in people with Cognition and Dementia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 80 years and olderHealthy volunteers can take part
Conditions the study is for
Cognition, Dementia
What is being tested?
CogniFit™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
2 sitesUnited States
Study dates
10 Mar 2011to 16 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Jewish Home Lifecare

    New York, New York, 10025

  • Icahn School of Medicine at Mount Sinia

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Read more

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.

Read the 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.

Conditions
Cognition, Dementia
Being tested
CogniFit™, Control-games
Keywords
computerized cognitive training
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CogniFit™Behavioural

    Also called Computerized cognitive training program

    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-gamesBehavioural

    Also called Computerized games program

    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.

Study groups in NCT03397498
Study groupRoleWhat they receive
Computerized cognitive trainingExperimentalReceived the Computerized cognitive training program, CogniFit™
Receives: Behavioral: CogniFit™
Control-gamesActive comparatorReceived the Computerized games program
Receives: Behavioral: Control-games

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Change in Memory Function

    A 10-item word list is presented over 3 trials (at the rate of 1 every 2 seconds) with a different word order each trial. The participant reads each word aloud as it is presented and then asked to recall as many words as possible. The range is 0 - 10 for each trial, with a Trial Total of 30. After a short delay the participant is asked to recall as many of the 10 words as they can. Word List Recognition: Immediately after the Delayed Recall task, the participant is asked to identify the 10 words from the list of target words and ten distractor words. There is a max of 10 correct 'Yes' responses and 10 correct 'No' responses. To adjust for chance, the score is calculated as the total number of correct answers minus 10. A Savings score is calculated to reflect the ability to recall learned information after a delay; this score is obtained by dividing the number of words recalled after the delay by the total number correct on Trial 3 and compared at completion of program to baseline.

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

  2. Change in Logical Memory Story A

    The LM subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story verbatim (immediate recall). Approximately 20 or 30 min later, free recall of the story is again elicited (delayed recall). at completion of program as compared to baseline.

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

  3. Change in Attention/Executive function score

    Attention/Executive function score - composite of Target Cancellation Tests (diamond and TMX); Trail Making Test (Parts A and B); Digit Symbol Substitution Test; and Digit Span tests (Forward and Backward) at completion of program as compared to baseline.

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

  4. Change in Language function score

    Language function score - composite of Similarities; Boston Naming Test; and Category Fluency and Letter Fluency tests at completion of program as compared to baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start10 Mar 2011
  3. Primary completion16 Dec 2014
  4. Study completion16 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397498
Sponsor's protocol ID
GCO 09-2339
Status last verified
Jan 2018
First submitted
5 Jan 2018
Last updated
12 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CogniFit™ in people with Cognition and Dementia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Global Cognition Composite (time frame: Baseline and after completion of program (approximately 7-8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.

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