The main objective of the study is to collect digital data for the tests that are currently hosted on the Cognitive Dx platform and to use this data to develop and refine the existing algorithms that automatically score the test. Secondary…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Algorithmic outcome of the automated scoring of the tests mentioned and manual
scoring of the tests
Secondary outcome
A list of measures that are significantly different for the two groups and a
profile of combined measures that is significantly different for the two groups.
Results of the questionnaire and interview of how the system was experienced by
the two different groups and a list of recommendations on how the system can be
improved for assessing people with Alzheimer*s Disease
Background summary
There is a need for digital neuropsychological tests. Philips created a digital
Cognitive Dx platform with neuropsychological tests that are derived from
digitizing existing tests. Digital tests make automatic scoring and analysis
possible. In order to exploit the full value to the Cognitive Dx platform we
need to develop state-of-the-art algorithms to both automatically detect
relevant features but also to classify these and provide automatic scoring
Study objective
The main objective of the study is to collect digital data for the tests that
are currently hosted on the Cognitive Dx platform and to use this data to
develop and refine the existing algorithms that automatically score the test.
Secondary objectives are comparing specific digital measures, or combination of
digital measures, that are generated by the algorithms and to discover if these
are different for Early Stage Alzheimer Disease (AD) patients as compared to
healthy individuals and the evaluation of the usability of the digitized test
platform in the healthy and AD population.
Study design
The digitized tests will be administered to 80 healthy participants and 80 AD
patients. The participants will be recruited by the company Silverbrains. They
will recruit AD patients and their partner or relative (as healthy
participants) from either a proprietary database of elderly individuals or via
healthcare institutions that often see AD patients. The study requires a single
visit to the patients' home with a maximum study duration of 1 hour for the
partner or relative and 2 hours for the AD patient.
Study burden and risks
There are negligible risks of using the software, Ipad and laptop in the
current set up. The research will be performed by a trained psychologist, who
has experience in conducting neuropsychological tests with AD patients. The
duration of participation is limited to 1,5 hours for the healthy participants
and 2 hours for AD patients. To mitigate the risk of fatigue in patients with
AD we will split the 2 hours into two equal halves. The patients will rest for
1,5 hours between each halve. There will only be one home visit required. There
is no direct benefit to the participants, but they will contribute and enable
the development of a product which can contribute to the improvements of
neuropsychological tests and improve the existing diagnostics of cognition. In
conclusion, the risks associated with participation can be considered
negligible and the burden minimal.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
For AD patient:
1. Aged 18 and older
2. Fluent/correct speaker in Dutch
3. AD patient is able to give consent
4. AD diagnosis by a clinical specialist, such as a geriatrician or neurologist
5. Being able to perform the neuropsychological tests with an Ipad
6. AD patient living at home (not at a nursing home)
7. Date of AD diagnosis < 2yr;For healthy participant:
1. Partner of relative of a patient with AD
2. Fluent/correct speaker in Dutch
3. Able to provide informed consent
4. Aged 18 and older
Exclusion criteria
For AD patient;
1. Unable or incompetent to give written informed consent
2. Severe communication deficits
3. Unable and/or unwilling to use a tablet to perform the tests
4. Medical history of neurological and/or psychiatric disorders (except for AD)
5. Mild Cognitive Impairment (MCI), vascular dementia, frontotemporal or mixed dementia diagnosis
6. Traditional neuropsychological assessment in the last 6 months
7. Bad eyesight or hearing, even with correction
8. Unable to properly use hands
9. An average alcohol consumption of 4 or more units per day
10. Use of one or more of the following types of medicine: antipsychotics, benzodiazepines, antidepressants, opioids, lithium, anti-epileptics, anti- Parkinson medication
11. Use of drugs;For healthy participant:
1. Unable or incompetent to give written informed consent
2. Medical history of neurological and/or psychiatric disorders
3. Traditional neuropsychological assessment in the last 6 months
4. Bad eyesight or hearing, even with correction
5. Unable to properly use hands
6. An average alcohol consumption of 4 or more units per day
7. Use of one or more of the following types of medicine: antipsychotics, benzodiazepines, antidepressants, opioids, lithium, anti-epileptics, anti- Parkinson medication
8. Use of drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61122.041.17 |
| Other | NTR identificatienummer nog niet toegekend |
| OMON | NL-OMON27881 |