A European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild to Moderate Alzheimer*s disease - NILVAD study

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 77 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•-prior diagnosis of mild to moderate AD based on NINCDS-ADRDA criteria
•-age range: males and females over age 50 years.
•-SMMSE score greather than or equal to 12, and less than 27
•-stable dose (>3 months of cholinesterase inhibitor and or memantine). Subjects who are not on cholinesterase inhibitors or memantine due to poor tolerability and/or who will not require treatment with these medications during the course of the study can be included.
•-Collateral informants such as a spouse, family member, close friend. The informant must have close contact with the subject and agree to monitor/manage study drug adherence, observe for possible adverse events, assist with psychometric measures requiring informant information, and accompany the subject to all evaluation visits.
•-Fluency in relevant language sufficient to reliably complete all study assessments.
•-Systolic BP between 100 mmHg and 159 mmHg, and diastolic BP between 65 mmHg and 99 mmHg on resting office based BP measurements, or a Systolic BP between 105 mmHg and 140 mmHg, and diastolic BP between 70 mmHg and 90 mmHg on ABPM measurement.
•-written informed consent of patient and collateral informant

•-Diagnosis of significant neurological disease other than AD
•-Subjects currently taking any calcium channel blocker or betablocker
•-Subjects who in the opinion of the investigator, have a medical condition that would preclude them from participating in the study (e.g.hemodynamically significant coronary artery disease., chronic heart failure, syncope within the past year, significant valvular heart disease i.e. severe aortic and mitral stenosis.. symptomatic orthostatic hypotension within the last year, subjects requiring more than one agent to control BP.), or subjects who in the opinion of the investigator are unlikely to complete per protocol due to care issues etc.
•-Current Axis I diagnosis of schizophrenia, bipolar disorder, major depression. Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence.
•-Subjects with a history of hypersensitivity to nilvadipine (Nivadil).
•-Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, whichever is longer, prior to baseline.
•(remaining, see protocol 4.3);substudy 3 (CBF): MRI-contra indication (metal implants, claustrophobia)

发起方

niversitair Medisch Centrum Sint Radboud