cognitive disorders intellectual disability mild cognitive impairment
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subject of >= 45 years of age at screening. 2. Cognitive disorders defined as mild cognitive impairment diagnosed by a neurologist, suspected due to neurodegenerative disease or non-neurological disorder (e.g. psychiatric disorders). 3. Willing and able to voluntary sign the informed consent form (ICF). 4. Willing and able to communicate with the investigator and site staff and to comply with the study requirements and visits.
Exclusion criteria
Exclusion criteria: 1. Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs, which, in the opinion of the Investigator, does not allow study participation. 2. Any previously diagnosed dementia or other neurodegenerative disease at or prior to screening 3. Any current, clinically significant, known neurological cause of cognitive disorders at or prior to screening. 4. Inability to willfully sign the informed consent document, supported by an MMSE < 24 at screening. Exceptionally, patients with an MMSE < 24 can be included only if the rationale is clearly documented by the investigator (i.e., clear reasoning why/how the patient can willfully sign the ICF, despite the MMSE score < 24), and there is an explicit non-objection to trial participation from the treating neurologist (which should be documented). 5. Recent infection with hospital admission < 2 months prior to screening. 6. A positive urine drug test (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamine, MDMA) or positive alcohol breath test at screening. 7. Consume, on average, more than 8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and unable to abstain from (methyl)xanthines from 24h before Day 1 and Day 28 up until completion of the in-clinic measurements on Day 1 and on Day 28. 8. History of clinical evidence of alcohol- or drug abuse. 9. Concerning concomitant medication: a) First use of any concomitant medication within 28 days prior to Day 1, with the exception of incidental use of paracetamol and/or NSAIDs. b) Dose change of pre-existing concomitant medication within 28 days prior to Day 1, with the exception of stopping medication more than 7 days or 5 times the half-life before Day 1 (whichever is longer). 10. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study) 11. Loss of blood >= 500 mL within 3 months before screening. 12. Does not own a smartphone on which the MORE application can be installed (Android 7.0 or above) 13. If a woman: pregnant, or breast-feeding, or planning to become pregnant during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is to compare the resting state EEG in patients with a non-neurological and neurodegenerative etiology of their cognitive complaints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the assessing diagnostic accuracy of: - composite of parameters registered by Trial@Home wearables as a proxy for daily activity, and - peak latency and amplitude of event related potentials in patients with a non-neurodegenerative and neurodegenerative aetiology of their cognitive complaints | — |
Countries
Netherlands
Outcome results
None listed