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Cross-sectional characterisation of elderly using the NeuroCart.

Cross-sectional characterisation of elderly using the NeuroCart. - Cross-sectional NeuroCart study in elderly.

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43551
Enrollment
1000
Registered
2016-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease dementia

Interventions

None listed

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)