Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease

Exclusion Criteria

• •Difficulty with the oral intake of tablets
• •Patients receiving anti-dementia drugs who have changed the dosing regimen during the 2 months prior to giving informed consent
• •Patients with dementia due to pathology other than Alzheimer's disease (e.g., vascular dementia, frontotemporal dementia, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, Huntington's disease, and prion disease)
• •Presence of clinically relevant or unstable mental disorders. Patients with major depression in remission can be enrolled.
• •Imminent risk of self-harm or harm to others
• •Body mass index (BMI) of \<= 17 or \>= 35
• •Patients with a history of alcohol dependence, drug dependence, or drug abuse within the 5 years before providing informed consent
• •HBs antigen positive
• •Anti-HIV antibody positive
• •Anti-HTLV-1 antibody positive
• •Patients with an active infection, such as hepatitis C and syphilis (STS/TPHA)
• •Patients with the following liver function values on the test before enrollment
• •AST(GOT) \> 4.0 x Upper limit of the institutional reference range or
• •ALT (GPT) \> 4.0 x Upper limit of the institutional reference range
• •Patients who have uncontrolled, clinically significant medical conditions (e.g., diabetes melitus, hypertension, thyroid/endocrine disease, congestive cardiac failure, angina pectoris, cardiac/gastrointestinal disease, dialysis, and abnormal renal function with an estimated CLcr \< 30 mL/min)within 3 months prior to giving informed consent in addition to the underlying disease to be investigated in the trial and for whom the investigator or sub-investigator considers that there is a significant medical risk in the patient's participation in the trial
• •Patients with long QT syndrome or tendency toward prolonged QTc interval (male: \>=470 msec, female: \>= 480 msec), or patients with a history/complication of torsades de pointes
• •Patients with a history of malignancies within 5 years prior to providing informed consent. However, patients with the following diseases can be enrolled if they are treated appropriately:
• •Skin cancer (basal cell, squamous cell)
• •Cervical carcinoma in situ
• •Localized prostate cancer
• •Malignancies that have not recurred for at least 3 years since surgery and the patient's physician has determined that the risk of recurrence is low
• •Patients with clinically significant vitamin B1/B12 deficiency or folic acid deficiency within 6 months prior to giving informed consent
• •Patients who have participated in other clinical research/trials involving interventions within the 3 months prior to providing informed consent
• •Patients who have previously received bromocriptine or TW-012R
• •Patients with a history of hypersensitivity to bromocriptine or ergot alkaloids
• •Patients with current or a history of thickened heart valve cusps, restricted heart valve motion, and the associated heart valve lesions, such as stenosis, confirmed by echocardiography
• •Pregnant females, lactating females, females who may be pregnant, and females who wish to become pregnant
• •Other patients who are considered inappropriate to participate in this trial at the discretion of the investigator or sub-investigator