Cognitive ImpairmentcogntionNCT06378606
Effect of Technology on Cognitive Function in Elderly
A study testing cognitive therapy in people with Cognitive Impairment, run by Nourhan Hesham Ali at 1 site in Egypt.
Trial summary
Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jun 2024
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 1- Age ≥ 65 years. 2- Literate with ≥ 15 years of education. 3- Older adults with mild dementia. 4- Montreal cognitive assessment score 18-26 .( Pinto et al .,2019). 5- Android smartphone user. 6- Well ability to write and read. Exclusion criteria
- Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.
- Alzheimer's disease.
- Sever cognitive dementia.
- Sever hearing difficulty or visual disturbance.
- Brain injury.
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- Limitation in communications.
- Chronic kidney diseases.
- Liver diseases.
- Low or high educated.
- Uncontrolled diabetic patients.
- Thyroid disturbance.
- Mental and psychological instability .
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nour Ali
Cairo, Giza Governorate, 12511
Nour Ali, master, 01156860154, nourheshame854@gmail.com
About this study
Official title: Effect of Screen Based Cognitove Therapy on Mild Dementi in Elderly
Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.
Read the detailed description
Aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. A significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (MCI). Currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. As such, the WHO has suggested that preventing cognitive decline and dementia is a global mental health priority. In addition to impacting the patient, dementia also has a significant impact on the family and society in general. Age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. Non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. Over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded .
Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.
- Conditions
- Cognitive Impairment
- Being tested
- cognitive therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive therapyBehavioural
Also called cognitive training
intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement .
group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | (Therapy group) It will include subjects that will receive computer based cognitive therapy sessions training.
omega 3 supplement . Receives: Behavioral: cognitive therapy |
| Group B | Experimental | (Smartphone group) It will include subjects that will receive home program training by using their smartphones cognitive applications .
omega 3 supplement . Receives: Behavioral: cognitive therapy |
| group c | Placebo comparator | It won't receive interventions. only omega 3 supplement Receives: Behavioral: cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions assessment
Cognitive function :
It was assessed by rehacom software and Montreal cognitive assessment (MoCA) which are a highly sensitive and specific screening tool for patients with impaired cognitive function. 1- Rehacom software screening: 9 screening modules detect cognitive functions: 4Attention, 2memory, 1logical reasoning and 2 visual field.
Montreal test is a short in duration (10- 15 min) 30-point screening test that measures a number of cognitive domains such as visuospatial abilities, executive function, short-term memory, attention/concentration, language, abstract thinking, and orientation. . Patients with MoCA scores of less than 26 are considered cognitively impaired Arabic version was used
Measured: 1 year
Secondary outcomes (1)
Quality of life survey
Quality of life : it was assessed by SF-12 health survey quality of life questionnaire.
The SF-12 is a generic, standardized questionnaire used to meas- ure two components of HRQoL: physical and mental health. . It is a shorter, yet valid alternative to the most widely used health status scale: the Short-Form-36 Health Survey Questionnaire (SF-36). The SF-12 reproduces the physical and mental component summary scores (PCS/MCS) of the SF-36. In addition, as the SF-12 contains fewer questions and takes less time to complete than the SF-36, it is more appropriate for use with older adults with common geriatric diseases, such as dementia .There scores range from zero (lowest HRQoL)-100 (highest)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Jul 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nourhan Hesham Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Nourhan Hesham Ali, Cairo University
- Investigators
- ahmed mahdi ahmed, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378606
- Sponsor's protocol ID
- P.T.REC/012/004907
- Acronym
- cogntion
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Screen Based Cognitove Therapy on Mild Dementi in Elderly
- ClinicalTrials.gov ID
- NCT06378606
- Acronym / sponsor ID
- cogntion / P.T.REC/012/004907
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nourhan Hesham AliUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.
Detailed description
Aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. A significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (MCI). Currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. As such, the WHO has suggested that preventing cognitive decline and dementia is a global mental health priority. In addition to impacting the patient, dementia also has a significant impact on the family and society in general. Age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. Non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. Over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded .
Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Behavioral: cognitive therapy(Therapy group) It will include subjects that will receive computer based cognitive therapy sessions training. omega 3 supplement . |
| Group B | Experimental | Behavioral: cognitive therapy(Smartphone group) It will include subjects that will receive home program training by using their smartphones cognitive applications . omega 3 supplement . |
| group c | Placebo comparator | Behavioral: cognitive therapyIt won't receive interventions. only omega 3 supplement |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 1- Age ≥ 65 years. 2- Literate with ≥ 15 years of education. 3- Older adults with mild dementia. 4- Montreal cognitive assessment score 18-26 .( Pinto et al .,2019). 5- Android smartphone user. 6- Well ability to write and read. Exclusion criteria
- Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.
- Alzheimer's disease.
- Sever cognitive dementia.
- Sever hearing difficulty or visual disturbance.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive therapyAlso: cognitive trainingintervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement . group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only. | Behavioural | Group B, group A, group c |
Primary outcome
Cognitive functions assessment
Time frame: 1 year
Cognitive function : It was assessed by rehacom software and Montreal cognitive assessment (MoCA) which are a highly sensitive and specific screening tool for patients with impaired cognitive function. 1- Rehacom software screening: 9 screening modules detect cognitive functions: 4Attention, 2memory, 1logical reasoning and 2 visual field. Montreal test is a short in duration (10- 15 min) 30-point screening test that measures a number of cognitive domains such as visuospatial abilities, executive function, short-term memory, attention/concentration, language, abstract thinking, and orientation. . Patients with MoCA scores of less than 26 are considered cognitively impaired Arabic version was used
1 secondary outcome
Quality of life survey
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed mahdi ahmed study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive therapy in people with Cognitive Impairment, run by Nourhan Hesham Ali at 1 site in Egypt.
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 13 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nourhan hisham ali (01156860154, nourheshame854@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functions assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.