Verification of safety of guanfacine for BPSD (Behavioral and psychological symptoms of dementia) positive symptoms of dementia

JRCT ID: jRCTs031220715

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dementia
• Date of first enrollment: 20/03/2023
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Off-label use of guanfacine hydrochloride extended-release tablets to improve positive BPSD symptoms of dementia

Outcome(s)

• Primary Outcome: Frequency and rate of adverse events

Secondary Outcome

(1) Efficacy ratings (NPI, DBD, and ADHD-RS scores)
(2) Cognitive function tests (ABC Dementia Scale scores)
(3) Evaluation of wobble (time to stand on one leg)
(4) Evaluation of drowsiness as a side effect
(5) Incidence of light-headedness, drowsiness, falls, and hypotension as side effects

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Those with positive BPSD symptoms due to Alzheimer's disease, frontotemporal dementia, or vascular dementia
(2) Those who are 60 years old or older at the time of obtaining consent
(3) Gender: any gender
(4) After receiving sufficient explanation of the study, and with full understanding of the subject, if the subject's free and voluntary written consent can be obtained, consent will be obtained from the subject, and written consent will also be obtained from a surrogate.
If it is difficult to obtain consent from the individual due to the underlying disease, written consent will be obtained from a surrogate.
(5) Those who are in contact with family members or caregivers for more than 10 hours per week
(6) Those who can go to the outpatient clinic according to the research implementation schedule

Exclude criteria

(1) Those with heart block on ECG or prolonged QT time of 0.46 seconds or more
(2) Those with a history of hypersensitivity to guanfacine
(3) Those with orthostatic hypotension
(4) Those with serious hepatic, renal, or circulatory disorders (to be determined with reference to Grade 3 of the JCOG version of CTCAE version 5.0)
(5) Those complicated with malignant tumor
(6) Those who have had a myocardial infarction or syncope within 6 months of consent
(7) Those weighing less than 40 kg
(8) Those with a history of serious drug allergy such as anaphylactic shock or a history of serious adverse drug reactions
(9) Those who do not have a medication supervisor during the study period
(10) Others who are judged inappropriate for participation in this study by the investigator or co-investigator

Related Information

• Primary Sponsor: Kameyama Yumi