Alzheimer DementiaNCT05113732
Association of Cognition With Functional Mobility in People With Alzheimer's Disease
An observational study of Alzheimer Dementia and Alzheimer's Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Dementia, Alzheimer's Disease, Dementia, Alzheimer Type
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 May 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with Alzheimer's disease
Who may be able to join
- Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Over 65 years old,
- Cases who could understand the instructions given in Turkish were included in the study,
- Having ambulation skill independently or with walking aid.
Who cannot join
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.
Read the detailed description
Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit\&Stand Test.
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assesment (MoCA)
MoCA assesses cognitive skills such as visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation. Higher scores reflect the better performance.
Measured: Baseline
Timed Up and Go Test
Timed Up and Go Test measures the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
Measured: Baseline
5 Time Sit to Stand Test
5 Time Sit to Stand Test measures the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Nur Menengiç, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113732
- Sponsor's protocol ID
- IUC-PT
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cognition With Functional Mobility in People With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05113732
- Acronym / sponsor ID
- IUC-PT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 9 Nov 2021 (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.
This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.
Detailed description
Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit\&Stand Test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with Alzheimer's disease
Key inclusion criteria (4 listed)
- Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Over 65 years old,
- Cases who could understand the instructions given in Turkish were included in the study,
- Having ambulation skill independently or with walking aid.
Key exclusion criteria (4 listed)
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Cognitive Assesment (MoCA)
Time frame: Baseline
MoCA assesses cognitive skills such as visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation. Higher scores reflect the better performance.
Timed Up and Go Test
Time frame: Baseline
Timed Up and Go Test measures the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
5 Time Sit to Stand Test
Time frame: Baseline
5 Time Sit to Stand Test measures the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia and Alzheimer's Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Nur Menengiç, MSc (+90 05054400987, kmenengic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assesment (MoCA) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 9 Nov 2021.