NL-OMON56487尚未招募不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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.
研究者
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