Mild Cognitive ImpairmentNCT03851198
Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
A study of Mild Cognitive Impairment, run by University of Malaga at 1 site in Spain.
Trial summary
The present study aims to develop an index formed by the variables, functional tests, scales and instruments that best discriminate between healthy subjects and subjects with MCI and that allows the stratification of different levels of severity of MCI, and to validate new systems for the early diagnosis of subjects… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 1 Sep 2021
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects over 60 years of age.
- Healthy subjects and subjects diagnosed with mild cognitive impairment.
- Subjects able of filling out questionnaires and performing functional tests.
Who cannot join
- Participants with neurological pathologies other than mild cognitive impairment.
- Participation in an experimental study where they receive a treatment.
- Score on the Mini-Mental State Examination of less than 24.
- Inability to get up from the chair at least 5 times or 30 seconds
- Inability to walk 20 meters.
- Inability to raise up both arms to 90 degrees or lifting 2 kg with the hand.
Show all 9Show fewer
- Inability to walk independently without a walking assistance device (cane, crutch or walker).
- Patients with prescription of beta-blockers.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to develop an index formed by the variables, functional tests, scales and instruments that best discriminate between healthy subjects and subjects with MCI and that allows the stratification of different levels of severity of MCI, and to validate new systems for the early diagnosis of subjects with mild cognitive impairment.
Read the detailed description
Dementia affects 46.8 million people and in 2050 it is expected that there will be between 115-135 million people suffering from dementia. Inside dementias, Mild Cognitive Impairment (MCI) has a prevalence in adults aged ≥65 years of 10-20%.
Patients with MCI also show greater progression towards dementia, higher mortality and disability, and a greater use of medical care compared to cognitively normal subjects that converts MCI into an important public health problem, which reinforces the need to perfect clinic assessment procedures to improve the early identification of individuals with MCI. Early diagnosis could allow effective medical treatments that prevent or slow the onset of dementia, and could improve the effectiveness of non-pharmacological interventions.
Currently, it can be used an Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Standard Care or Usual Clinical Practice
- Keywords
- Mild Cognitive Impairment, Diagnosis, Functional tests, Kinematics, Validation, Reliability
- Medical subject headings
- Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care or Usual Clinical PracticeProcedure or surgery
The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment patients | Experimental | Subjects diagnosed with mild cognitive impairment, who will receive the best treatment of clinical practice, will be recruited. They must be more than 60 years old. Receives: Procedure: Standard Care or Usual Clinical Practice |
| Healthy Subjects/ Match control | Active comparator | Healthy subjects of the same age as people with mild cognitive impairment. Receives: Procedure: Standard Care or Usual Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic analysis by motion sensor
An Inertial Sensor will pick up positioning, motion and acceleration information from the subject
Measured: 1 hour
Kinematic analysis by 3D motion capture
The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Measured: 1 hour
Responsiveness
The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Inertial Sensor and the 3D cameras. All possible items will be followed.
Measured: 1 hour
Reliability
The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Inertial Sensor and the 3D cameras. All possible items will be followed.
Measured: 1 hour
Validity
The Criterion Validity Box of COSMIN checklist will be used to determinate the correlation between data from the Inertial Sensor and the 3D camera. All possible items will be followed.
Measured: 1 hour
Secondary outcomes (7)
Mini-Mental State Examination (MMSE)
Questionnaire used for the cognitive state assessment. The Mini-Mental State Examination includes eleven questions. The maximum total score is 30 points. It is divided into two sections, the first of which requires only vocal responses and covers orientation, memory and attention; the maximum score is 21. The second part assess the ability to name, follow verbal and written commands, write a sentence spontaneously and copy a complex polygon similar to a Bender-Gestalt figure; the maximum score is 9. As usual, a score lower 24 points points is indicatives of dementia.
Measured: 15 min
Geriatric Depression Screening Scale (GDSS)
A questionnaire designed to detect depression in older adults. This scale consists of 30 items (answer format yes / no). Less score is indicative of depression. Generally, a score below 15 points is already indicatives of depression.
Measured: 15 min
Katz Index
It is a hetero-administered questionnaire used to assess activities of daily living that includes 6 dichotomous items (bathing, dressing, goimt to toilet, transfer, continence, feeding). It is scored considering the items individually, so that 0 points are given when the activity is performed independently and 1 point if the activity is done with help or not done. The score varies from 0 to 6 points, with a higher score indicative of greater dependence on the development of activities of daily living.
Measured: 15 min
Lawnton & Brody Scale
It is a hetero-administered questionnaire used to assess instrumented activities of daily living that includes the assessment of 8 activities of daily living (ability to use the telephone, shopping, food preparation, housekeeping, laundry, mode of transporation, responsibility for own medications and ability to handle finances). The score varies from 0 to 8 points. 0 points are given when the activity is performed independently and 1 point if the activity is done with help or not done. There is no cut-off point, but a higher score is indicative of worse performance of instrumental activities or less functionality.
Measured: 15 min
Cardiopulmonary function
The heart rate will be assessed using the Polar wrist heart rate monitor
Measured: 1 hour
Metabolic parameters
The blood lactate produced will be analysed using the Lactate Pro 2 blood lactate analyzer
Measured: 1 hour
Sonographic parameters
The thickness of the subcutaneous fat and the anterior rectus quadriceps muscle, and the eco-intensity of the subcutaneous fat and the anterior rectus quadriceps muscle, both at rest and in maximum voluntary isometric contraction, will be collected.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Apr 2020
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851198
- Sponsor's protocol ID
- IJFA07
- Status last verified
- Sep 2020
- First submitted
- 21 Feb 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the anonymised data that conform the results that will be analysed in the present clinical trial, after the de-identification, will be published in a peer review journal (tables, figures, appendices, text). Moreover, data will be available to researchers who provide a methodologically sound proposal, but data will be not publicly available. Proposals will be directed by acuesta@uma.es. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Patients With Mild Cognitive Impairment Through the Parameterization of Functional Tests.
- ClinicalTrials.gov ID
- NCT03851198
- Acronym / sponsor ID
- IJFA07
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Diagnosis, Functional tests, Kinematics, Validation, Reliability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Feb 2019 (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.
The present study aims to develop an index formed by the variables, functional tests, scales and instruments that best discriminate between healthy subjects and subjects with MCI and that allows the stratification of different levels of severity of MCI, and to validate new systems for the early diagnosis of subjects with mild cognitive impairment.
Detailed description
Dementia affects 46.8 million people and in 2050 it is expected that there will be between 115-135 million people suffering from dementia. Inside dementias, Mild Cognitive Impairment (MCI) has a prevalence in adults aged ≥65 years of 10-20%.
Patients with MCI also show greater progression towards dementia, higher mortality and disability, and a greater use of medical care compared to cognitively normal subjects that converts MCI into an important public health problem, which reinforces the need to perfect clinic assessment procedures to improve the early identification of individuals with MCI. Early diagnosis could allow effective medical treatments that prevent or slow the onset of dementia, and could improve the effectiveness of non-pharmacological interventions.
Currently, it can be used an Inertial Sensor and 3D motion capture systems with a camera to analyse kinematics and these instruments are being integrated as a rehabilitation tool in patients. The use of Inertial Sensor and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment patients | Experimental | Procedure: Standard Care or Usual Clinical PracticeSubjects diagnosed with mild cognitive impairment, who will receive the best treatment of clinical practice, will be recruited. They must be more than 60 years old. |
| Healthy Subjects/ Match control | Active comparator | Procedure: Standard Care or Usual Clinical PracticeHealthy subjects of the same age as people with mild cognitive impairment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects over 60 years of age.
- Healthy subjects and subjects diagnosed with mild cognitive impairment.
- Subjects able of filling out questionnaires and performing functional tests.
Key exclusion criteria (9 listed)
- Participants with neurological pathologies other than mild cognitive impairment.
- Participation in an experimental study where they receive a treatment.
- Score on the Mini-Mental State Examination of less than 24.
- Inability to get up from the chair at least 5 times or 30 seconds
- Inability to walk 20 meters.
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 |
|---|---|---|
| Standard Care or Usual Clinical PracticeThe guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care. | Procedure or surgery | Healthy Subjects/ Match control, Mild Cognitive Impairment patients |
Primary outcome
Kinematic analysis by motion sensor
Time frame: 1 hour
An Inertial Sensor will pick up positioning, motion and acceleration information from the subject
Kinematic analysis by 3D motion capture
Time frame: 1 hour
The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Responsiveness
Time frame: 1 hour
The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Inertial Sensor and the 3D cameras. All possible items will be followed.
Reliability
Time frame: 1 hour
The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Inertial Sensor and the 3D cameras. All possible items will be followed.
Validity
Time frame: 1 hour
The Criterion Validity Box of COSMIN checklist will be used to determinate the correlation between data from the Inertial Sensor and the 3D camera. All possible items will be followed.
7 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: 15 min
Geriatric Depression Screening Scale (GDSS)
Time frame: 15 min
Katz Index
Time frame: 15 min
Lawnton & Brody Scale
Time frame: 15 min
Cardiopulmonary function
Time frame: 1 hour
Metabolic parameters
Time frame: 1 hour
Sonographic parameters
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. All the anonymised data that conform the results that will be analysed in the present clinical trial, after the de-identification, will be published in a peer review journal (tables, figures, appendices, text). Moreover, data will be available to researchers who provide a methodologically sound proposal, but data will be not publicly available. Proposals will be directed by acuesta@uma.es. To gain access, data requestors will need to sign a data access agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mild Cognitive Impairment, run by University of Malaga at 1 site in Spain.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 7 Dec 2023. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Kinematic analysis by motion sensor (time frame: 1 hour). The study lists 5 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 7 Dec 2023.