Behavioral and Psychological Symptoms of Dementia. Alzheimer's disease
Conditions
Interventions
Intervention 1: Intervention group: agomelatine as add-on therapy, with the initial dose of 6.25 mg daily preferably in the afternoon for two days, which will be increased to 12.5 mg daily for three d
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI). Timepoint: Weeks 0 and 6. Method of measurement: Persian version of CMAI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadi Esmaily
Shahid Beheshti University of Medical Sciences
Outcome results
None listed