The goal of this clinical trial is to learn about safety and efficacy of bromocriptine in familial Alzheimer's disease with presenilin 1 mutations. The main questions it aims to answer are: •safety of bromocriptine •efficacy of bromocriptine Participants will answer questions, have blood exams, lumbar punctures and MRI/PET scans. Researchers will compare a participants group taking bromocriptine with a participants group taking placebo to see if there is any changes in cognitive function, and behavioral and psychiatric symptoms with dementia.
To investigate the safety and efficacy of an orally administered dose of TW-012R in patients with Alzheimer's disease bearing PSEN1 (presenilin 1) mutations (PSEN1-AD), using a placebo group as a control. In addition, long-term safety will be examined in an open-label extension trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Each tablet contains 2.87 mg of bromocriptine mesilate (JP) (2.5 mg of bromocriptine)
Identical tablets which contain no active ingredient
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Safety (Incidence and severity of adverse events and adverse reactions)
to assess safety
Time frame: Until Week 50 (end of trial)
Severe impairment battery-Japanese version (SIB-J)
to assess cognitive function
Time frame: Until Week 20 and 36
Neuropsychiatric Inventory (NPI)
to assess behavioral and psychiatric symptoms of dementia
Time frame: Until Week 20 and 36
Mental Function Impairment Scale (MENFIS)
to assess cognitive function
Time frame: Until Week 20 and 36
Mini-Mental State Examination-Japanese (MMSE-J)
to assess cognitive function
Time frame: Until Week 20 and 36
Disability Assessment for Dementia (DAD)
to assess activities of daily living
Time frame: Until Week 20 and 36
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
to assess motor symptoms and signs
Time frame: Until Week 20 and 36
Apathy Scale
to assess apathy
Time frame: Until Week 20 and 36
Plasma Aβ protein concentration
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Asakayama Hospital
Sakai, Osaka, Japan
Osaka University
Suita, Osaka, Japan
Tokushima University Hospital
Tokushima, Tokushima, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, Tokyo, Japan
to assess Aβ protein metabolism
Time frame: Until Week 20 and 36
Plasma NfL protein concentration
to assess neurodegeneration
Time frame: Until Week 20 and 36
Plasma Total Tau, Plasma p-Tau concentration
to assess tau protein metabolism
Time frame: Until Week 20 and 36
Cerebrospinal fluid (CSF) Aβ concentration
to assess Aβ protein metabolism
Time frame: Until Week 36
CSF Total Tau, CSF p-Tau concentration
to assess tau protein metabolism
Time frame: Until Week 36
Blood bromocriptine concentration
to assess safety
Time frame: Until Week 20 and 36