Long-term safety and efficacy of TK-023 in Patients with Severe Dementia of the Alzheimer's Type

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224612

Enrollment

Registered

2019-03-26

Start date

2019-03-31

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

Dementia of the Alzheimer's type

Interventions

investigational material(s) Generic name etc : Donepezil INN of investigational material : Donepezil Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnostic evidence of probable dementia of the Alzheimer's Type consistent with the Diagnostic and Statistical Manual for Mental Disorders-version V (DSM-V) 2. Mini-Mental State Examination (MMSE) score of 1 to 12 at Baseline 3. ABC dementia scale 13 at Baseline 4. Stable donepezil dose of 10 mg, taken as a single, daily dose for >= 3 months prior to the Screening Visit 5. Evidence consistent with Alzheimer's Type on any cranial image (CT or MRI) obtained within 24 months prior to the Screening Visit 6. Outpatient 7. Subjects who have a caregiver 8. Subjects who have been on a daily dose of donepezil hydrochloride 10 mg (any dosage form is applicable) for at least 3 months

Exclusion criteria

Exclusion criteria: 1. Subjects with dementia other than Alzheimer's type 2. Subjects with a cause of Dementia which is supported by any laboratory tests 3. Subjects with an active skin lesion/disorder that may affect adhesion and skin symptom assessment on the application site. 4. Subjects with history of photosensitivity 5. Subjects with allergy to component of donepezil hydrochloride (including excipients) or piperidine derivative. 6. Subjects with allergy to external preparation 7. Subjects unable to take donepezil hydrochloride 10 mg tablet 8. Subjects with history of TK-023 administration

Design outcomes

Primary

Measure	Time frame
safety Adverse events, Clinical laboratory values, Pregnancy tests, Vital signs, Body weight, 12-lead ECGs	—

Secondary

Measure	Time frame
efficacy 1. Changes from baseline to weeks 12, 24, 52 in MMSE score 2. Changes from baseline to weeks 12, 24, 52 in ABC dementia scale and TDD (three dimensional distance)	—

Countries

Japan

Outcome results

None listed

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