Alzheimer's disease, healthy volunteers, biomarker
Conditions
Interventions
fMRI memory task
fMRI perception task
fMRI resting state
Evoked related potentials
EEG based technique to measure longterm potentiation
auditory steady state response
Sponsors
Centre for Human Drug Research
Eligibility
Inclusion criteria
Inclusion criteria: All subjects: 1. Aged 50-75 years; 2. Ability to communicate well with the investigator in the Dutch language; 3. Willing to give written informed consent and to comply with the study restrictions; Additional inclusion criteria for the AD subjects are: 4. Diagnosed with probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria confirmed by the treating physician; 5. MMSE score 18-26 (inclusive); 6. CDR global rating score of 0.5 or 1.0 at screening; Additional inclusion criteria for the healthy controls are: 7. MMSE score ≥ 27.
Exclusion criteria
Exclusion criteria: All subjects: 1. Any contra-indications for MRI (prostheses, implants, claustrophobia, pacemakers, etc.); 2. Presence or history of alcohol abuse, or 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 upon admission to the Clinical Research Unit (CRU); 3. Use of tobacco and/or nicotine-containing products within 30 days of day 1; 4. Positive urine drug screen at screening or day 1; 5. Unable to refrain from use of (methyl) xanthine (e.g. coffee, tea, cola, chocolate) from 24 hours prior to day 1 until discharge from the CRU; 6. Use of concomitant medication which influences the central nervous system; 7. Concussion or other acute head trauma in the past six months. 8. A Geriatric Depression Scale – 15 (GDS) score ≥6; Exclusion criteria for AD subjects are: 9. Clinically relevant history of abnormal physical or mental health, other than AD, interfering with the study as determined by medical history taking obtained during the screening visit and/or at the start of day 1 as judged by the investigator (including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder). 10. Use of cholinesterase inhibitors, Memantine or herbal treatments such as Ginkgo Biloba. Exclusion criteria for healthy subjects: 11. Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and physical examinations obtained during the screening visit and/or at the start of day 1 as judged by the investigator (including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI memory task - BOLD activity fMRI perception task - BOLD activity EEG based technique to measure longterm potentiation- amplitudes and latencies auditory steady state response - gamma oscillations | — |
Secondary
| Measure | Time frame |
|---|---|
| fMRI resting state - default mode network Evoked related potentials - amplitude and latencies | — |
Contacts
Public ContactCharlotte Bakker
Outcome results
None listed