NL-OMON56487
Not Yet Recruiting
N/A
Assessment of clinical neurophysiological biomarkers for the differentiation of neurodegenerative disease versus non-neurological disorder in patients with mild cognitive impairment. - Clinical neurophysiological biomarkers in mild cognitive impairment.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cognitive disorders
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 30
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.,
Outcomes
Primary Outcomes
Not specified
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