Status:
COMPLETED
Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
Mie University
Osaka University
Conditions:
Familial Alzheimer Disease (FAD)
PSEN1 Mutation
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 o...
Detailed Description
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04413344
Start Date
June 5 2020
End Date
November 24 2021
Last Update
August 29 2025
Active Locations (8)
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1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
2
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
3
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
4
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan, 701-0192