Main objectives:To determine differences in NeuroCart profiles in different sub-groups based on cognitive testing and CSF biomarker profiling (i.e. cognitively normal, pre-symptomatic AD, prodromal AD, MCI, mild AD).To characterize a cohort of…
ID
Source
Brief title
Condition
- Neurological disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NeuroCart assessments
* Adaptive tracking test;
* Visual Verbal Learning Test (VVLT);
* Milner Maze test;
* Visual Analogue Scales according to Bond and Lader (VAS-BL); alertness, mood
and calmness;
* Face encoding and recognition test;
* N-back test;
* Sustained Attention to Response test (SART);
* 21 leads electroencephalogram (EEG)
* Event related potentials (ERPs; P50, P300, N100 and mismatch negativity
[MMN]);
Neuropsychological tests
* Animal fluency test;
* Clinical Dementia Rating scale (CDR);
* Alzheimer*s Disease Assessment Scale * Cognition (ADAS-Cog);
* Amsterdam Instrumental Activities of Daily Living scale (Amsterdam iADL);
* Pittsburgh Sleep Quality Index (PSQI).
Biochemical outcome variables
CSF biomarkers
* A* concentration (1-40, 1-42)
* Total tau concentration (Tau-t)
* Phosphorylated tau concentration (Tau-p)
* Exploratory markers (e.g. Neurogranin, VILIP-1)
Exploratory plasma biomarkers
* A* concentration (1-40, 1-42)
* Tau-t and Tau-p concentrations
* Acute phase & inflammatory proteins
Genetics
* APOE genotype
Secondary outcome
Not applicable
Background summary
The NeuroCart, a computerized battery of cognitive tests, is used in CHDR's
clinical trials to study pharmacodynamic drug effects. There is a growing
demand for studies in elderly subjects and further investigation of the use of
the NeuroCart in elderly is needed.
Study objective
Main objectives:
To determine differences in NeuroCart profiles in different sub-groups based on
cognitive testing and CSF biomarker profiling (i.e. cognitively normal,
pre-symptomatic AD, prodromal AD, MCI, mild AD).
To characterize a cohort of elderly subjects in order to yield norm scores for
specific NeuroCart tests in the different sub-groups that will be defined based
on cognitive testing and CSF profiling.
Exploratory objective:
To determine the correlation between AD-specific biomarkers in plasma and in
CSF (A* 1-40 and 1-42, tau proteins and exosomes) in this cohort of elderly
subjects.
Study design
This study is a cross-sectional, single occasion, observational study.
Study burden and risks
Burden:
The burden for the participants includes the time investment for the briefing,
screening, the occasion.
Risk:
No risks are considered. Only the taking of blood samples can be painful and
lead to bruising. The collection of CSF fluid via a lumbar puncture can be
painful and lead to post-punction headache.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
1. Males and females, aged 60 and older (inclusive);
2. Willing and able to perform the cognitive tests, as evidenced by performance on the training session of the cognitive tests.
3. Willing and able to give written informed consent and to comply with the study procedures.
Exclusion criteria
1. Legal incapacity or inability to understand or comply with the requirements of the study;
2. Evidence of severe cognitive deterioration, as indicated by a diagnosis of severe cognitive disorder (including but not limited to Alzheimer*s disease, Lewy Body Dementia, Fronto-temporal Dementia);
3. History or symptoms of significant psychiatric disease (including but not limited to clinical depression, schizophrenia);
4. A Mini Mental State Examination (MMSE) score of < 18;
5. A Geriatric Depression Scale (GDS) score of *6;
6. Presence of drug abuse, or positive urine drug screen (UDS) at screening or occasion;
7. Presence of severe alcohol abuse (daily alcohol consumption exceeding 2 standard drinks per day on average for females or exceeding 3 standard drinks per day on average for males (1 standard drink = 10 grams of alcohol)), or a positive breath alcohol test at screening or occasion;
8. Any other reason that it is not safe or ethical to allow a subject to participate in the study in the opinion of the investigator.
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 | NL55747.056.16 |