NCT04413344

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Kyoto University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Alzheimer Disease (FAD)
• PSEN1 Mutation

Interventions

Type	Name	Description
DRUG	Bromocriptine Mesilate	Each tablet contains 2.87 mg of bromocriptine mesilate (JP) (2.5 mg of bromocriptine)
DRUG	Placebos	Identical tablets which contain no active ingredient

Timeline

• Start date: 2020-06-05
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2020-06-02
• Last updated: 2025-08-29

Locations

8 sites across 1 country: Japan