NL-OMON50245尚未招募2 期
Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease - [18F]MC225 in neurodegenerative disease
适应症
试验速览
- 阶段
- 2 期
- 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. Alzheimer's disease (n=10)
- •Patients who meet the criteria for Alzheimer*s disease and are mentally
- •competent to give informed consent:
- •I. Documented cognitive decline
- •II. Progressive course of cognitive decline
- •III.Complaints in the following areas
- •b. language
- •c. visuospatial functions
- •d. executive functions
- •IV. Absence of cerebrovascular disease or signs of other neurodegenerative
- •disease except for Alzheimer*s disease.
- •and show biomarkers positive for AD:
- •I. amyloid-depositions in the brain showed by low Aβ42 in CSF and/or
- •positive amyloid imaging at a PIB-PET
- •II. Neuronal damages showed by increased tau/ptau in CSF or;
- •decreased FDG uptake at the parietotemporal lobe or;
- •disproportional atrophy of the medial, basal and lateral temporallobes,
- •generalised atrophy and/or biparietal atrophy.
- •2. Mild Cognitive Impairment (n=10)
- •Patient is not meeting the criteria for Alzheimers disease, but shows:
- •- Decline in one or more cognitive domains (showed by a neuropsychological
- •examination)
- •- No interference of symptoms with daily life
- •The diagnosis Alzheimer*s disease is made by a multidisciplinary team
- •consisting of psychiatrists, neurologists, psychologists and internists.
- •- Absence of cerebrovascular disease or signs of other neurodegenerative
- •disease except for MCI
- •The diagnosis MCI is made by a multidisciplinary team consisting of
- •neurologists, psychologists and internists
- •3. Parkinson's disease
- •Symptoms of bradykinesia and one of the following symptoms (25):
- •- rigidity
- •- rest tremor
- •- instability (not related to visual, cerebellar or proprioceptive disorders)
- •- no other explanation for abovementioned symptoms at MRI
- •- The diagnosis Parkinson*s disease is made by a neurologist
- •- Absence of cerebrovascular disease or signs of other neurodegenerative
- •disease except for Parkinson*s disease
- •The diagnosis Parkinson*s disease is made by a neurologist.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- History of neuropsychiatric disorders such as epilepsy, major depression, or
- •schizophrenia
- •- Claustrophobia
- •Use of medication with known P-gp influence, according to the
- •Farmacotherapeutisch Kompas:
- •- Digoxine
- •- Dabigatran
- •- Everolimus
- •- Verapamil
- •- Tacrolimus
- •- Rosuvastatin
- •- Lercanidipin
- •- Repaglinide
- •- Aliskiren
- •- Aminoglycosides
- •- Vancomycine
- •- Acyclovir
- •- Trimethoprim
- •- Amfotericine B
- •- Ciprofloxacine
- •- H2 receptor antagonists
- •- Methotrexate
- •- St. John*s Wort
- •- Loperamide
- •- Rifampicine
- •- Carbamazepine
- •- Fenobarbital
- •- Fenytoine
- •- Hypericum
- •- Primidon
- •The list contains pharmaceuticals with P-gp influence mentioned in the FK, for
- •other pharmaceuticals, the influence on P-gp will be checked using kennisbank
- •KNMP or Pubmed)
- •Exclusion Criteria contrast-enhanced MRI:
- •- Metallic objects or fragments placed in the body
- •- Artificial metal joints or implants
- •- Pacemaker
- •- Clips/Stents in blood vessel
- •- Claustrophobia
- •- a history of mastocytosis
- •- Pregnancy or breastfeeding
- •- Kidney failure (< 45 ml/min)
- •- Allergy to MR contrast or dye
- •- Tattoo (>20cm)
研究者
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