A Phase III Study of TK-023 in Patients with Mild to Moderate Dementia of the Alzheimer's Type

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224517

Enrollment

328

Registered

2019-01-15

Start date

2019-01-18

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) at Screening 2. Hachinski Ischemic Score 71 at Baseline 4. Mini-Mental State Examination (MMSE) score of 10 to 26 at Baseline 5. ADAS-Jcog score > 15 at Baseline 6. Subjects who have a caregiver

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

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory ADAS-Jcog score and changes from baseline at 24 weeks of double-blind period	—

Secondary

Measure	Time frame
efficacy 1. ADAS-Jcog score and changes from baseline (4-12 weeks) 2. ADL assessment: DAD score and changes from baseline (4-24 weeks) 3. Clinical global impression of change rating: ABC dementia scale and the changes from baseline (4-24 weeks) 4. ADAS-Jcog score, the changes from baseline/24th week (28-52 weeks) 5. Clinical global impression of change rating: ABC dementia scale and the changes from baseline/24th week (28-52 weeks)	—

Measure

Time frame

efficacy 1. ADAS-Jcog score and changes from baseline (4-12 weeks) 2. ADL assessment: DAD score and changes from baseline (4-24 weeks) 3. Clinical global impression of change rating: ABC dementia scale and the changes from baseline (4-24 weeks) 4. ADAS-Jcog score, the changes from baseline/24th week (28-52 weeks) 5. Clinical global impression of change rating: ABC dementia scale and the changes from baseline/24th week (28-52 weeks)

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Countries

Japan

Outcome results

None listed

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