Evaluation of the Efficacy of Agomelatine as Add-on Therapy on the Aggression, Agitation, and its Relationship with Serum Brain-Derived Neurotrophic Factor (BDNF) of Patients with Alzheimer’s disease Dementia; A Double-blind, Randomized, Placebo-controlled Clinical Trial

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 56 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

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•Female and male patients 50 years of age and older
•Being able to provide written informed consent or have written informed consent provided by a legally authorized representative (LAR) on behalf of the patient
•Diagnosis of Alzheimer’s dementia (according to NINCDS-ADRDA) with a FAST score of 4 to 6 (inclusive)
•Suffering from aggression and/or agitation that developed after the onset of dementia and must be severe enough to disrupt their functioning and occurred nearly daily or most of the days per week during the week prior to enrolment (or a score of > 39 on the Cohen-Mansfield Agitation Inventory)
•If female must be of non-childbearing potential or must agree to use a clinically acceptable method of contraception or abstinence during the study.

•The patient or caregiver is unable to comply with the study visits
•Syndromes overlapping with Alzheimer’s dementia (vascular dementia is not an exclusion criterion)
•Behavioral and psychological symptoms of dementia (BPSD) developed by other medical causes
•Recent alcohol or substance abuse disorder
•Current smokers
•Secondary causes of Alzheimer’s disease (such as down syndrome)
•Patients diagnosed with epilepsy
•History of head trauma that had caused loss of consciousness
•Patients diagnosed with Parkinson’s disease, frontotemporal dementia, Lewy body dementia, dementia following stroke
•Diagnosis or history of psychotic disorders such as schizophrenia, schizoaffective disorder, delusional disorder, bipolar mood disorder)
•Consumption of antipsychotics and/or melatonin during the past two weeks prior to screening
•Concomitant strong CYP1A2 inhibitor medications consumption
•Patients with a disease of clinical significance or unstable conditions (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, unstable pulmonary, renal, or hepatic disease, unstable ischemic heart disease, malignancy)

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