Healthy subjects with Alzheimer biomarkers/pathology Nervous System Diseases
Conditions
Interventions
In total subjects are asked to visit the research unit twice. Screening to determine eligibility will take place within 21 days before the study day. This study involves a single study day, which will
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 |
|---|---|
| Performed as training to reduce learning effect during screening and once during the study day. 1. Attention measured using the Adaptive tracking test 2. Memory measured using the Visual Verbal Learning Test (VVLT) 3. Spatial measured using working memory the Milner Maze test 4. Episodic measured using memory the Face encoding and recognition test 5. Working measured using memory the N-back test 6. Vigilance measured using the Sustained Attention to Response test (SART) 7. Motor activation and fluency measured using the Finger tapping task Performed once during the study day only: 8. Level of cognitive impairment measured using the Clinical Dementia Rating scale (CDR) 9. Level of independence measured using the Instrumental Activities of Daily Living scale (IADL) 10. Handgrip strength of dominant hand measured using the JAMAR hydraulic hand dynamometer 11. Several biomarkers in CSF and plasma related to dementia/AD measured using: 11.1. Aß concentration (1-40, 1-42 and 1-42/1-40 ratio) 11.2. T-Tau and p-Tau concentrations 11.3. NfL concentration. 12. Genetic disposition for developing Alzheimer’s disease measured using blood sample to determine APOE e genotype 13. Three blood samples were taken during the study day to determine several biomarkers related to dementia/AD: 13.1. Synaptic loss; Neurogranin 13.2. Glial inflammation; YKL-40 13.3. Levels of p-Tau181 in extracts of neutrally-derives blood exosomes 13.4. MicroRNAs [MiR-155, MiR-107 and MiR-29] | — |
Countries
Netherlands
Contacts
Public ContactSamantha Prins
Outcome results
None listed