Randomised Clinical Trial of Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer'sDisease - NorAD

Imperial College London0 个研究点目标入组 160 人开始时间: 2016年7月13日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•NINCDS/ADRDA criteria for probable AD
•MMSE at assessment = 10-30.
•Identified informant to accompany patient at all visits
•Patient must have been on stable dose of donepezil, galantamine or rivastigmine for preceding 12 weeks
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•Labile blood pressure or new antihypertensive medication started within 3 weeks;
•Severe coronary insufficiency or myocardial infarction in previous 6 months;
•History of unexplained syncope within the preceding 12 months; Cardiac Conduction Block
•Severe Hepatic Impairment (ALT > 120 (Upper Limit of Normal (ULN) is 40) OR Alkaline Phosphatase > 390 (ULN is
•130)) OR Both ALT and total bilirubin > ULN OR Total bilirubin > 60 (ULN is 30) ; Severe Renal Impairment (eGFR<40)
•(Lower Limit of Normal is 59)
•Treatment with other medications known to potentiate guanfacine’s hypotensive effects or cause arrhythmia
•(specifically antipsychotics (including sultopride,
•chlorpromazine, thioridazine, amisulpiride, sulpiride, haloperidol), and moxifloxacin, baclofen, verapamil, quinidine,
•hydroquinidine, dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimazide, bepridil, cisapride, diphemanil,
•erythromycin, halofantrine, pentamidine, sparfloxacin, vincamine, alfuzosin, prazosin, terazosin, tamsulosin,
•amifostine;
•weight less than 45kg (In order to ensure that an excessive dose per body weight is not used in the study).
•Pregnancy (Pre-menopausal women will only be entered into the study of they are surgically sterile or using effective
•birth control methods: These are abstinence for the period of the study, intrauterine contraception/device, male sexual
•partners with vasectomy)

发起方