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Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1/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

NCT04413344•Kyoto University

View on ClinicalTrials.gov

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 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.

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 control. In addition, long-term safety will be examined in an open-label extension trial.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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
+18 more criteria

Locations (8)

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

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

Key Dates

Start Date

June 5, 2020

Primary Completion Date

November 24, 2021

Completion Date

November 24, 2021

Last Updated

August 29, 2025

Enrollment

ACTUAL participants

Conditions

Familial Alzheimer Disease (FAD)PSEN1 Mutation

Interventions

Bromocriptine Mesilate

DRUG

Placebos

DRUG

China Cognition and Aging Study

NCT03653156

Mild Cognitive Impairment(MCI)Alzheimer Disease, Late Onset+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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