Clinical Trials List
2017-08-01 - 2020-04-30
Phase III
Terminated12
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-10G30
Alzheimer's disease
ICD-9331.0
Alzheimer's disease
A multinational, multi-center, randomized, double-blind, active comparator, phase III clinical trial to evaluate the efficacy and safety of donepezil transdermal patch in patients with Alzheimer’s disease
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Trial Applicant
Clinipace Taiwan Co., Ltd
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Sponsor
ICURE PHARM. INC.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 鄧浩文 Division of Neurology
- Chin-I Chen Division of Neurology
- Chih-Shan Huang Division of Neurology
- Jia-Ying Sung Division of Neurology
- JOWY TANI Division of Neurology
- Hsing-Yu Weng Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ming-Jang Chiu Division of Neurology
- 程郁文 Division of Neurology
- HSUEH-WEN HSUEH Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張維泓 Division of Psychiatry
- Wei-Pin Hong Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Kuan-Fei Chen Division of Neurology
- Jui-Cheng Chen Division of Neurology
- Yi-Chien Yang Division of Neurology
- Yu-Wan Yang Division of Neurology
- Hung-Yu Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 王炯垚 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 呂建榮 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- PO-LIN CHEN Division of Neurology
- WEI-JU LEE Division of Neurology
- 李毓珊 Division of Neurology
- 郭怡真 Division of Geriatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Dean Wu Division of Neurology
- Chaur-Jong Hu Division of Neurology
- Po-Chih Chen Division of Neurology
- Shu-Ping Chao Division of Neurology
- Li-Kai Huang Division of Neurology
The Actual Total Number of Participants Enrolled
14 Stop recruiting
Audit
None
Taiwan National PI
Co-Principal Investigator
- KuoLun Huang Division of Neurology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- 黃玲鈞 Division of Neurology
- MEI-CHUAN CHOU Division of Neurology
The Actual Total Number of Participants Enrolled
18 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
① Change at Week 24 of treatment with the study drug from baseline (0d) in ADAS-cog
scores
② CIBIC-plus score at the end of treatment (Week 24)
2) Secondary efficacy endpoints
① Change at Week 12 of treatment with the study drug from baseline (0d) in ADAS-cog
scores
② Change at Week 24 of treatment with the study drug from screening (-2W) in MMSE
③ Change at Weeks 12 and 24 of treatment with the study drug from baseline (0d) in ADCSADL
④ Change at Week 24 of treatment with the study drug from baseline (0d) in NPI
A. Change in total score of intensity (frequency X severity)
B. Change in total score of pain intensity
⑤ Change at Weeks 12 and 24 of treatment with the study drug from screening (-2W) in
global CDR scores and CDR sum of Box scores
⑥ Medication convenience (10 point VAS) at the end of treatment (Week 24) (0 point:
completely dissatisfied, 10 points: completely satisfied) and patch adherence during
treatment (0 point: did not adhere most or all of the time, 10 points: adhered perfectly every
time)
Inclution Criteria
1) Age of ≥50 to ≤85 as of the date of informed consent
2) Clinical diagnosis of probable Alzheimer’s disease according to Diagnostic and Statistical
Manual of Mental Disorders 4
th Edition (DSM-IV) and National Institute of Neurological
and Communicative Disorders and Strokes; Alzheimer’s disease and Related Disorders
Association (NINCDS-ADRDA)
3) Mini Mental Status Examination (MMSE) score ≥10 to ≤26 at screening
4) Global Clinical Dementia Rating (CDR) score 0.5, 1 or 2 at screening
5) Capable of performing procedures for cognitive and other tests
6) Subject who meets any of the following as of the date of informed consent
No past treatment with donepezil (naïve patient)
Ongoing treatment with donepezil 10mg/day for the past 3 months
Ongoing treatment with donepezil 5mg/day for the past 3 months
7) The subject or his/her representative must voluntarily decide to participate in the study and
provide written informed consent.
8) The subject must have a reliable caregiver who regularly contacts the subject and is
available to accompany the subject for on-site visits. (Note: A caregiver is defined as
someone who has regular contact with the subject [i.e., an average of approximately 10 or
more hours per week], must be able to oversee subject’s compliance with the study
treatment and to report on the patient’s status and must be able to accompany the subject to
all study visits.)
Exclusion Criteria
1) Possible, probable, or definite vascular dementia according to National Institute of
Neurological Disorders and Stroke/Association Internationale pur la Recherche et
I’Enseignement en Neurosciences (NINDS-AIREN)
2) History and/or evidence (computed tomography [CT] or magnetic resonance
imaging [MRI] findings obtained within the past 12 months or at screening) of
other central nervous system (CNS) disorders (cerebrovascular disease, structural
or developmental anomaly, epilepsy, or communicable, degenerative, or
infectious/demyelinating CNS conditions) as a cause of dementia
Note: >3 lacunar infarcts over 10 mm each, or severe white matter disease
equaling a rating of 3 on the age-related white matter changes (ARWMC scale)
should be excluded in the study.
3) Illiteracy
4) Treatment with other anti-dementia drugs (galantamine, memantine, rivastigmine,
tacrine), except donepezil, within the past 3 months from the date of informed
consent
5) Treatment with any of the following drugs within the past 2 weeks from the date
of informed consent
- CNS stimulants: methylphenidate, modafinil, pemoline, atomoxetine
- Typical antipsychotics: bromperidol, chlorpromazine, haloperidol
- Anticholinergics: atropine, glycopyrrolate, scopolamine, homatropine,
ipratropium (short term [within 3 days] use of anticholinergics for the
purpose of antispasmodic action on the digestive system is permitted.)
6) Abnormal blood test findings as follows at the screening test:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
≥2.5 x upper limit of normal
- A serum creatinine level of ≥1.5 × ULN for the reference laboratory, or a
calculated creatinine clearance by the Cockcroft-Gault equation of
≤50mL/min
7) Clinically significant abnormal vitamin B12, syphilis serology, or thyroid stimulating hormone (TSH) test findings considered to contribute to the severity
of dementia or to be attributable to dementia
Note:
(a) Clinically significant untreated B12 should be excluded in the study. Subjects
are eligible if B12 deficiency is stable after the treatment.
(b) If the subject has tested False positive for syphilis test, based on the
investigator's judgment, further test can be performed to get the final result.
(c) TSH >10mIU/L should be excluded in the study.
8) Diagnosis of serious mental disease based on DSM-5 criteria, including
depressive disorder,, schizophrenia, alcoholism, drug dependency, etc.
9) Parkinson’s disease or parkinsonian syndrome
10) Clinically significant electrocardiogram (ECG) abnormalities at screening (heart
rate <50 beats/min, atrial and ventricular conduction disorders such as 2nd degree
atrioventricular block, QTc interval >480ms)
11) History of unstable angina pectoris, myocardial infarction, transient ischemic
attack, or coronary intervention including coronary bypass within the past
6 months from the date of informed consent
12) History of severe traumatic head injury with loss of consciousness within the past
6 months from the date of informed consent
13) Asthma or obstructive pulmonary disease requiring medication
14) Gastrointestinal disorders that may affect the absorption, distribution, and
metabolism of the study drug (e.g., inflammatory bowel disease, gastric or
duodenal ulcer, hepatic disease)
15) Uncontrolled diabetes mellitus (defined as HbA1c>9.0%)
16) Administration of other investigational products within 3 months prior to
treatment with the investigational product (Day 0)
17) Hypersensitivity reactions to donepezil HCl, piperidine derivatives, or any of the
components of the study drug
18) Pregnant or lactating woman or woman of childbearing potential who does not
agree to use an effective method of contraception
19) Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or
glucose-galactose malabsorption
20) Individual considered by the investigator to be ineligible for study participation
for other reasons, including having a condition that may affect the assessment of
study results
The Estimated Number of Participants
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Taiwan
125 participants
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Global
376 participants
