Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease - A cholinergic challenge preceding galantamine treatment in patients with AD

Centre for Human Drug Research0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Outpatients
•- Diagnosis of probable AD (according to NINCDS-ADRDA)26
•- Severity of dementia must be mild to moderate according to Clinical Dementia Rating Score (CDR of 0.5 - 2)
•- No contraindication for treatment with a CEI
•- Mini Mental State Exam score of 18-26 inclusive
•- Assessed by the treating neurologist as mentally capable of understanding the implications of study participation
•- Presence of an informant/caregiver at the information visit, signing of informed consent, and all study visits
•- Signed informed consent by patient and caregiver

•- Bedridden
•- Severe asthma
•- Metabolic disorders interfering with absorbtion, distribution or excretion of galantamine
•- Pre-existing psychiatric disease
•- Other causes that can explain cognitive symptoms
•- Use of neuroleptics
•- Use of anticholinergics (e.g. oxybutinin, mebeverine, ipratropium(bromide))
•- Use of benzodiazepine within 48 hours before a study day
•- Prior or current use of a CEI (rivastigmine, galantamine, donepezil)
•- Alcohol abuse (defined as use of alcohol despite significant areas of dysfunction, evidence of physical dependence, and/or related hardship due to alcohol)
•- Use of recreational drugs
•- Concomitant use of inhibitors of CYP2D6 (a/o kinidine, paroxetine, fluoxetine) or of CYP3A4 (a/o ketoconazol, ritonavir)
•- Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.

发起方