The primary objective of this study is to assess the performance of selected RMTs against standardised rating scales of ADLs in subjects with preclinical AD, MCI due to AD, and mild-to-moderate AD, and FTD. Secondary objectives are, (a) to evaluate…
ID
Source
Brief title
Condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between healthy volunteers, preclinical AD, MCI due to AD, and
mild-to-moderate AD and FTD in outcome measures of ADL using selected RMTs.
Secondary outcome
Difference between healthy volunteers, preclinical AD, MCI due to AD, and
mild-to-moderate AD and FTD in the following assessments performed in the
clinic or in real-life of the following: 1) difficulties at work; 2) spatial
navigation & memory; 3) planning skills; 4) managing finances; 5) self-care; 6)
self-management; 7) acquiring new skills; 8) sleep quality and cardiac rhythms;
9) use of technology/devices; 10) dysnomia, word finding difficulties; 11)
gait; 12) difficulties driving; 13) interpersonal interaction; 14) motivation,
signs of apathy or withdrawal.
Background summary
Alzheimer*s Disease (AD) is associated with staggering costs and suffering,
which are particularly related to the social impacts of caring for increasingly
disabled individuals. These functional disabilities can be almost undetectable
in the early stages of the disease, worsening over time often and at a varying
rate of progression in different people. The measurement of such functional
disabilities is typically blunt and relies on direct observation or caregiver
recall. Digital technologies, particularly those based on the use of
smartphones, wearables and/or home-based monitoring devices, here defined as
*Remote Measurement Technologies* (RMTs), provide an opportunity to change
radically the way in which functional assessment is undertaken in AD, RMTs
have the potential to obtain better measurements of behavioral and biological
parameters associated with individual Activities of Daily Living (ADL) when
compared to the current subjective scales or questionnaires. Divergence from
normative ADL profiles could objectively indicate the presence of specific
functional disabilities even at the very early stages of AD. Therefore, the
main hypothesis of this project is that RMTs should allow the detection of
impairments in functional component of ADLs that occur below the threshold of
clinical scale detection or disability questionnaires.
Study objective
The primary objective of this study is to assess the performance of selected
RMTs against standardised rating scales of ADLs in subjects with preclinical
AD, MCI due to AD, and mild-to-moderate AD, and FTD. Secondary objectives are,
(a) to evaluate associations between RMTs and standard clinical scales used to
characterise people with AD diagnosis, (b) to investigate the patient
acceptability of selected RMTs used for the duration of the study, and (c) to
assess the technical performance of RMTs and digital platform in a real-life
setting.
Study design
A multicentre observational cross-sectional cohort digital assessment study.
Tier 1 lasts 8 weeks and involves wearable technologies such as smartphones and
-watches. Tier 2 lasts 4 weeks and involves fixed sensors at home. Tier 1 and 2
can be in parallel or start after each other. If tier 2 starts after tier 1,
the Fitbit will be worn for an additional 4 weeks.
Study burden and risks
Tier 1: subjects will visit the clinic at least twice: once for a baseline
visit and once at the end of the study. During these visits, information
gathering, clinical profiling, neurophysiological testing and training in the
use of RMTs will be performed. Up to three telephone interviews will be held
during the study duration of 8 weeks to assess user experience, technical
problems with the RMTs and adverse events. The study will not have any direct
benefits for participants. Tier 2: participants from tier 1 can participate
optionally in tier 2. A house visit will take place in which movement sensors
will be installed in the house and in the car. After 2 weeks, a telefphone
interview will be held to assesss user experience, technical problems and
adverse events. After 4 weeks, another house will will take place to deinstall
the devices.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
All subjects:
- Over 50 years of age
- Study partner available
- In otherwise good health condition or with diagnosis mild chronic disorder or
any other affections that are controlled by therapy and/or do not impair
function on a secondary basis to that of AD-related symptomatology.
- Subject and study partner own a smartphone
Additional for subjects with Alzheimer's Disease:
- Diagnosis of Alzheimer's Disease based on the presence of amyloid load AD
biomarkers
Additional for healthy controls:
- No cognitive deficits at the screening visit
Additional for probable bvFTD (n =15)
- Diagnosis of probable bvFTD based on diagnostic criteria of Rascovsky et al.,
2011
- FTDL-CDR (0-1)
Exclusion criteria
- Presence of an additional neurological or psychiatric disease that may affect
ADL or social interactions.
- Any other kind of disorders that relevantly affect mobility and/or ADL or
social interac-tions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70374.029.19 |