Double-blind comparative study followed by open-label extension study to evaluate the efficacy and safety of TW-012R in Alzheimer's disease with presenilin 1 mutations(Phase 2/3 Study)

Double-blind comparative study followed by open-label extension study to evaluate the efficacy and safety of TW-012R in Alzheimer's disease with presenilin 1 mutations(Phase 2/3 Study) - REBRAnD2

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041250040

Enrollment

Registered

2025-05-29

Start date

2025-06-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presenilin1 gene mutation in Alzheimers disease patients Dementia, Alzheimers disease, familial, genetic, presenilin 1

Interventions

[Double-blind period] 1) Low-dose maintenance period Initiate oral administration of one tablet of the investigational drug (TW-012R or placebo) once a day immediately after breakfast on the next day

D001971

Bromocriptine, Dopamine-agonist

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) AD patients with PSEN1 mutations identified by genetic testing 2) Patients diagnosed with "probable Alzheimer's disease" according to the diagnostic criteria for AD in DSM-5 3) Patients with a clear decline in cognitive function and daily living function based on medical records or information from informants who know the patient well 4) Patients with an MMSE-J score of 2-19 at Week 0 (Visit 2) 5) Patients with a caregiver who can provide the subject information necessary for this clinical trial, properly manage medication, and accompany the patient on scheduled visits 6) Patients aged 18 years or older at the time of obtaining consent 7) Patients or their legal representatives have given written consent to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Those who have difficulty taking tablets orally. 2) Patients with the following diseases that the investigator judges to affect cognitive function or cognitive function evaluation (nutritional deficiency, metabolic disease, infectious encephalopathy, diabetes, hypertension, thyroid/endocrine disease, VB1/VB12 deficiency, folic acid deficiency) 3) Patients with a history of alcoholism, drug dependence, or drug abuse within 5 years prior to obtaining consent 4) Patients taking anti-dementia medication, whose dosage or administration has changed within 2 months prior to obtaining consent 5) Patients whose SIB-J score has worsened by -1.85/week or more (number of weeks rounded up to the nearest whole number) from the start of screening (Visit 1) to 0 weeks (Visit 2) 6) Patients with dementia due to a condition other than AD (vascular dementia, frontotemporal dementia, dementia with Lewy bodies, progressive supranuclear palsy, corticobasal degeneration, Huntington's disease, prion disease, etc.)

Design outcomes

Primary

Measure	Time frame
SIB-J	—

Contacts

Public ContactClinical Development Department

TOWA PHARMACEUTICAL Co.,LTD.

rinsho-kanja@towayakuhin.co.jp+81-6-6991-5515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026