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IRCT20200711048075N1 IRCT 2020-07-29 National Institute for Medical Research Development Effect of Hydralazine on Alzheimer’s disease The effect of Hydralazine on early stage of Alzheimer’s disease: A randomized clinical trial 2020-09-22 anticipated 424 Complete https://irct.ir/trial/49556 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The treatment allocation ratio for the two treatment arms will be 1:1. The random sequence will be extracted and the randomization process will be permuted block randomization. Each block consists of four participants. Treatment scheme which will be generated by sealed envelope (https://www.sealedenvelope.com/) website. The prepackaged study medications complied by Iran FDA, will be delivered at the pharmacy of YRH to each participating patient. The medications will be provided in identical boxes. Each box will bear a unique medication identification number, Blinding description: The participant, outcome assessors, researchers and data analyzer will be blinded to the study arms.The site personnel will be blinded to the medication and treatment assignment. The EHSAN website will assign the blinded medication box numbers for the patient. The box number will be assigned based on the random treatment scheme generated by the website. For each subsequent refill of study medication, the site will log on to the EHSAN website to obtain a new medication box number, which will also be linked to the randomization scheme. The patient will begin treatment the same day as randomization. The study blind will not be broken at the time a patient is withdrawn from the trial. The blind will be broken at the conclusion of the trial for all randomized patients. 3 Alzheimer’s disease. Intervention 1: Intervention group: Hydralazine 75mg (25mg three times per day). Intervention 2: Placebo 25 mg TDS. Yes - There is a plan to make this available What will be shared: Study protocol, code books and data files When: َAfter study site close down by the study monitor To whom: ِِonly available for people working in academic institutions. Conditions: Chief Investigator: mmirzaei@ssu.ac.ir User and password will be provided for external monitors to have access to the study Case Report Form (CRF) Where to obtain: Chief Investigator: mmirzaei@ssu.ac.ir User and password will be provided for external monitors to have access to the study Case Report Form (CRF) How to obtain: Contacting the Chief Investigator: mmirzaei@ssu.ac.ir Comments:
public Nastaran Ahmadi
Yazd Cardiovascular Research Centre, Afshar Heart Centre, Jomhouri Blvd, Yad-Iran
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3523 1421 ahmadi.psy@gmail.com Yazd University of Medical Sciences scientific Masoud Mirzaei
Yazd Cardiovascular Research Centre, Afshar Hospital, Jomhouri Blvd.
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3523 1421 masoud_mirzaei@hotmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA). Presence of a caregiver (friend or relative) who can assume responsibility for medication administrations, accompany the patient to all visits, and rate patient's condition. Written informed consent from both the patient (or surrogate) and caregiver. An MMSE score between 12 and 26 inclusive. Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (3-6mg/d), galantamine or galantamine ER (8-16mg/d) for a minimum of 4 weeks prior to randomization. Agreement not to take Hydralazine. Age 49 and over 49 years no limit Both A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia, vitamin B-12 deficiency, hypothyroidism). Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV. Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year. Currently being treated with Hydralazine or a history of intolerance to oral therapy with Hydralazine Any intravenous treatment for heart failure, except IV furosemide (e.g. IV inotropes, pressors, nitrates or nesiritide) at the time of screening. Systolic blood pressure <100 mmHg Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction-over the past 4 weeks, arrhythmia and pacing device (Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min). Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) and severe aortic or mitral stenosis or severe rheumatic mitral regurgitation. Concurrent use of phosphodiesterase type 5 (PDE5) inhibitors (e.g. Viagra, Sildenafil. Etc.) Have had cardiac revascularisation within the last 3 months or are likely to require coronary revascularisation within the study period. eGFR< 15ml/min/1.73m2, or on regular dialysis, or planned dialysis within the study period G30.0 Alzheimer's disease with early onset Treatment - Drugs Placebo Intervention group: Hydralazine 75mg (25mg three times per day) Placebo 25 mg TDS The progression of of Alzheimer's disease. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: ADAS-cog inventory. Function of Alzheimer's patients. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Lawton Activity of Daily Living Scale. Cognition of Alzheimer's patients. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Mini Mental State Examination. Behavior of Alzheimer's patients. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Nero-Psychiatry Inventory. Caregiver time. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Caregiver Activity Scale. Olfactory sense. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Olfactory test. Drug side effects. Timepoint: Before the intervention - 3/6/9/12 months after the start of the intervention. Method of measurement: Blood biochemistry tests. Kereshmeh Food Co. National Institute for Medical Research Development Kereshme Food Co. Approved 2019-06-16 National Institute for Medical Research No. 21, Besat St. W. Fatemi Ave. Tehran-Iran Tehran Tehran Iran (Islamic Republic of)