2024-518865-85-00招募中2 期
BBB-PET; Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Regionale PET tracer uptake en influx waarden van [18F]MC225
研究概览
简要总结
Evaluation of [18F]MC225 to measure the P-glycoprotein function in Alzheimer’s disease, Mild Cognitive Impairment and Parkinson’s disease.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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 a. memory 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.
- •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
- •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 - NSAIDs - 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)
结局指标
主要结局
Regionale PET tracer uptake en influx waarden van [18F]MC225
Regionale PET tracer uptake en influx waarden van [18F]MC225
次要结局
- CBF - cerebral blood flow values obtained with [15O]H2O PET MRI (vessel architecture) VAI measurements Arterial samples replaced with less invasive venous samples
研究者
dr. Gert Luurtsema
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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