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REBRAnD

CompletedPhase 1 / PHASE2

Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease

Double-Blind Comparative Trial and Open-Label Extension Trial to Investigate the Safety and Efficacy of TW-012R in Alzheimer's Disease With Presenilin 1 (PSEN1) Mutations

Lead sponsor

Kyoto University

Asset

Bromocriptine Mesilate

Listed sites

8

Recruiting sites

-

Enrollment

8

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤25•Study partner/caregiver required

Primary endpoints

•Safety•Severe impairment battery-Japanese version (SIB-J)•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIACT19029
NCT IDNCT04413344

Timeline

Milestones

Study first posted2020-06-02actual
Study start2020-06-05actual
Primary completion2021-11-24actual
Study completion2021-11-24actual
Last update posted2025-08-29actual

Assets

Drug assets

Bromocriptine Mesilate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Global cognition
3
Tau biomarkers
3
Function / daily living
2
Behavior / neuropsychiatric
2
Safety / tolerability / PK
2
Amyloid biomarkers
1
Neurodegeneration biomarkers
1
Fluid / digital biomarkers
1

Global cognition

3 endpoints
Primary/protocol endpoint

Severe impairment battery-Japanese version (SIB-J)

Time frame:Until Week 20 and 36

descriptive

Secondary/protocol endpoint

Mental Function Impairment Scale (MENFIS)

Time frame:Until Week 20 and 36

descriptive

Secondary/protocol endpoint

Mini-Mental State Examination-Japanese (MMSE-J)

Time frame:Until Week 20 and 36

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

2 endpoints
Secondary/protocol endpoint

Disability Assessment for Dementia (DAD)

Time frame:Until Week 20 and 36

descriptive

Other/protocol endpoint

Wearable physical activity meter

Time frame:Until Week 20 and 36

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Until Week 20 and 36

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Apathy Scale

Time frame:Until Week 20 and 36

descriptive

Amyloid biomarkers

1 endpoint
Other/protocol endpoint

Brain amyloid PET image

Time frame:Until Week 36

descriptive

Tau biomarkers

3 endpoints
Secondary/protocol endpoint

Plasma Total Tau, Plasma p-Tau concentration

Time frame:Until Week 20 and 36

concentration, descriptive

Secondary/protocol endpoint

CSF Total Tau, CSF p-Tau concentration

Time frame:Until Week 36

concentration, descriptive

Other/protocol endpoint

Brain tau PET image

Time frame:Until Week 36

descriptive

Neurodegeneration biomarkers

1 endpoint
Secondary/protocol endpoint

Plasma NfL protein concentration

Time frame:Until Week 20 and 36

Neurofilament light (NfL)

concentration, descriptive

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Cerebrospinal fluid (CSF) Aβ concentration

Time frame:Until Week 36

concentration, descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Safety (Incidence and severity of adverse events and adverse reactions)

Time frame:Until Week 50 (end of trial)

event count, event

Secondary/protocol endpoint

Blood bromocriptine concentration

Time frame:Until Week 20 and 36

concentration, descriptive

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

Time frame:Until Week 20 and 36

descriptive

Secondary/protocol endpoint/low confidence

Plasma Aβ protein concentration

Time frame:Until Week 20 and 36

concentration, descriptive

Other/protocol endpoint/low confidence

Finger tapping sensor readout

Time frame:Until Week 20 and 36

descriptive

Other/protocol endpoint/low confidence

Upper motor neuron burden score

Time frame:Until Week 20 and 36

descriptive

Other/protocol endpoint/low confidence

Plasma Aβ-related peptides concentration

Time frame:Until Week 20 and 36

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.