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

Phase 3

Conditions: Behavioral and Psychological Symptoms of Dementia.
Alzheimer's disease

Registration Number: IRCT20170608034390N10

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 56

Inclusion Criteria

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.

Exclusion Criteria

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield Agitation Inventory (CMAI). Timepoint: Weeks 0 and 6. Method of measurement: Persian version of CMAI.

Secondary Outcome Measures

Name	Time	Method
evel of serum Brain-derived neurotrophic factor (BDNF) from baseline. Timepoint: Weeks 0 and 6. Method of measurement: Blood sampling and specific BDNF kits.;Frequency of adverse drug reactions. Timepoint: Throughout the study. Method of measurement: Recording and evaluation of adverse events.