Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease

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.

Conditions

• Familial Alzheimer Disease (FAD)
• PSEN1 Mutation

Interventions

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

Sponsors & Collaborators

• Mie University

  collaborator OTHER

• Osaka University

  collaborator OTHER

• Tokushima University

  collaborator UNKNOWN

• Tokyo Metropolitan Institute for Geriatrics and Gerontology

  collaborator UNKNOWN

• Asakayama Hospital

  collaborator UNKNOWN

• Kawasaki Medical School Hospital

  collaborator UNKNOWN

• Nagoya City University Hospital

  collaborator UNKNOWN

• Time Therapeutics, Inc.

  collaborator UNKNOWN

• Towa Pharmaceutical Co.,Ltd.

  collaborator UNKNOWN

• Kyoto University

  lead OTHER

Principal Investigators

• Haruhisa Inoue, MD, PhD · Kyoto University

• Hidekazu Tomimoto, MD, PhD · Mie University Hospital

• Haruhiko Banno, MD, PhD · Kyoto University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-05

Primary Completion

2021-11-24

Completion

2021-11-24

Countries

• Japan

Study Locations