Alzheimer's Disease dementia
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 50- 80 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 or 2 at screening; Additional inclusion criteria for the healthy controls are: 7. MMSE score * 27.
Exclusion criteria
Exclusion criteria: 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 reduces the level of alertness; 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 in patients with mild AD. 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 |
|---|---|
| Biomarker: * Picture recognition task (Episodic memory) probing novelty and subsequent memory (Maass et al., 2014, Nature Communications) o Blood oxygen level dependent (BOLD) fMRI activity in the hippocampus and entorhinal layers/sub-regions o Subsequent memory performance (i.e .hit rate) * Visual perception task probing layer specific memory processing (Meppelink et al., 2009, Brain) o Blood oxygen level dependent (BOLD) fMRI activity in the visual areas * Resting state fMRI o functional connectivity within the default mode network (DMN) * Clinical neurophysiology o 40 Hz Auditory steady state response * gamma oscillations - Gamma-band intertrial phase coherence - Gamma-band evoked power o MMN - MMN amplitude - MMN latency o P300 - P300 amplitude - P300 latency o Visual Evoked Potentials (VEP) based technique to measure LTP - N75 amplitudes and latencies - P100 amplitudes and latencies - N135 amplitudes and latencies Safety: - (serious) adverse events ((S)AEs). - Concomitant medication | — |
Countries
Netherlands
Outcome results
None listed