Assessment of clinical neurophysiological biomarkers for the differentiation of neurodegenerative disease versus non-neurological disorder in patients with mild cognitive impairment.
- Conditions
- cognitive disordersintellectual disabilitymild cognitive impairment
- Registration Number
- NL-OMON56487
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint is to compare the resting state EEG in patients with a<br /><br>non-neurological and neurodegenerative etiology of their cognitive complaints.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include the assessing diagnostic accuracy of:<br /><br>- composite of parameters registered by Trial@Home wearables as a proxy for<br /><br>daily activity, and<br /><br>- peak latency and amplitude of event related potentials<br /><br><br /><br>in patients with a non-neurodegenerative and neurodegenerative aetiology of<br /><br>their cognitive complaints</p><br>