Effect of Hydralazine on Alzheimer's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two arms will be randomly allocated to either hydralazine hydrochloride 25mg TDS or placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Hydralazine hydrochloride was imported directly from a global supplier, packed in 90 tablet bottles with a specific batch number for drug and placebo not revealed to any of the above parties.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 49 years and 125 years
- Gender
- Both males and females
Description
Study aim: Determination and comparison of the effect of 75mg (25mg TDS) hydralazine vs. placebo in patients with mild to moderate Alzheimer's disease. Development of an electronic Case Report Form (CRF) and push notification system to remind patients (and/or caregivers) of drug intake to improve dr...
Study aim: Determination and comparison of the effect of 75mg (25mg TDS) hydralazine vs. placebo in patients with mild to moderate Alzheimer's disease. Development of an electronic Case Report Form (CRF) and push notification system to remind patients (and/or caregivers) of drug intake to improve drug intake adherence and reduce follow-up losses. Evaluation of the prognostic accuracy of olfactory tests to predict the changes in cognition and performance of patients with mild to moderate Alzheimer's disease. Design: This is a phase III, triple-blind, parallel double-armed randomized clinical trial with an allocation ratio of 1-1 to the intervention and placebo arms. This trial will be conducted on 424 randomly selected patients using random permuted blocks. Settings and conduct: All patients who are identified as potentially eligible by the supporting neurologists and psychiatrists will be referred to Adineh Clinic to evaluate their cognitive function, assess for inclusion and exclusion criteria and obtain informed consent. The two arms of the study are hydralazine 75mg (25mg three times per day) or hydralazine placebo. A follow-up evaluation will continue for one year after drug administration. The participants, outcome assessors, researchers, and data analyzers will be blinded to the study arms. Participants/Inclusion and exclusion criteria: patients over the age of 49 and over who are diagnosed with mild to moderate AD will be included in this study; dementia patients with etiologies other than AD (i.e. vascular dementia) will not be included. Intervention groups: The two arms of the study are Hydralazine 75mg (25mg three times per day) or Hydralazine placebo. Main outcome variables: Various cognitive and function tests for patients and caregivers, olfactory tests, biochemistry as well as drug side effects will be assessed regularly over the period of follow-up.
Tracking Information
- NCT #
- NCT04842552
- Collaborators
- National Institute for Medical Research Development (NIMAD), Iran
- McMaster University
- Investigators
- Study Chair: Hamid Mirzaei, PhD Shahid Sadoughi University of Medical Sciences
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