Eligibility |
Inclusion Criteria:
- Alzheimer's disease patients with PSEN1 mutations
- Patients diagnosed with "probable AD" according to the diagnostic guideline of NIA-AA
or "probable Alzheimer-type dementia" according to the diagnostic criteria for
Alzheimer's disease specified in DSM-5
- An MMSE-J score of <= 25
- Patients whose cognitive function and everyday function are obviously impaired based
on their medical record or information provided by a person who knows the patient well
- Patients for whom intellectual disability and mental disorders other than dementia can
be ruled out based on their academic background, work history, and life history.
- Patients with a reliable and close relationship with a partner/caregiver
- Age>=20 years at the time of giving informed consent
- Written informed consent has been obtained from the patient or his/her legally
acceptable representative to participate in this trial
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
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