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

Phase 3

Completed

• Conditions: Dementia of the Alzheimer's type

• Registration Number: JPRN-jRCT2080224612
• Lead Sponsor: TEIKOKU SEIYAKU Co., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2021-08-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 70

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 < 85 and > 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Adverse events, Clinical laboratory values, Pregnancy tests, Vital signs, Body weight, 12-lead ECGs

Secondary Outcome Measures

Name	Time	Method
efficacy<br>1. Changes from baseline to weeks 12, 24, 52 in MMSE score<br>2. Changes from baseline to weeks 12, 24, 52 in ABC dementia scale and TDD (three dimensional distance)