Neurodegenerative disorders Alzheimer's disease Dementia
Conditions
Interventions
Alzheimer
Biomarkers
Healthy elderly
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Males and females, aged 65 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 cognitive deterioration, as indicated by a diagnosis of a cognitive disorder (including but not limited to MCI, Alzheimer*s disease, Lewy Body Dementia, Fronto-temporal Dementia); 3. History or symptoms of significant psychiatric disease in the past 3 years (including but not limited to clinical depression, schizophrenia); 4. A Mini Mental State Examination (MMSE) score of *24; 5. A Geriatric Depression Scale * 15 (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 contradictions for a lumbar puncture as judged by the principal investigator. 9. 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| NeuroCart assessments - Adaptive tracking test; - Visual Verbal Learning Test (VVLT); - Milner Maze test; - Face encoding and recognition test; - N-back test; - Sustained Attention to Response test (SART); - Finger tapping. Neurophysiological NeuroCart assessments - 21 leads electroencephalogram (EEG); - Smooth and saccadic eye movement. Neuropsychological tests - Clinical Dementia Rating scale (CDR); - Instrumental Activities of Daily Living scale (IADL). Handgrip strength - JAMAR hydraulic hand dynamometer Biochemical outcome variables CSF biomarkers - A* concentration (1-40, 1-42 and 1-42/1-40 ratio); - T-Tau and p-Tau concentrations; - NfL concentration. Plasma biomarkers - A* concentration (1-40, 1-42); - T-Tau and p-Tau concentrations; - NfL concentration. Genetics - APOE * genotype. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory biomarkers including but not limited to: - Synaptic loss; Neurogranin [24], - Glial inflammation; YKL-40 [25], - Levels of p-Tau181 in extracts of neutrally-derives blood exosomes [26], - MicroRNAs [MiR-155, MiR-107 and MiR-29 [27]]). | — |
Countries
The Netherlands
Outcome results
None listed