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Trial registered on ANZCTR


Registration number
ACTRN12617001066370
Ethics application status
Approved
Date submitted
4/07/2017
Date registered
21/07/2017
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An interventional study to evaluate the efficacy and safety of a donepezil transdermal patch compared to oral Aricept in Alzheimer's disease
Scientific title
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
Secondary ID [1] 292214 0
NIL
Universal Trial Number (UTN)
Trial acronym
IPI-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate Alzheimer’s disease 303709 0
Condition category
Condition code
Neurological 303079 303079 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two study groups in this clinical study. Participants who meet the inclusion/exclusion criteria will be randomized to either the test group or the comparator group (1:1).
For the test group the participant will receive donepezil in the form of a transdermal patch (the test drug IPI-301) which will be attached to the participant’s back. The participant will also take a placebo comparator Aricept (donepezil) tablet.
For the comparator group the participant will take Aricept (donepezil) tablets. The participant will also attach a placebo transdermal patch to their back.
Participants who have been on stable treatment with oral donepezil 5mg or 10mg will be prescribed the same dose of either the test drug or the comparator during the study period.
- Participants who have been on oral donepezil 5mg before will receive a transdermal patch IPI-301 (87.5mg/25cm2) or Aricept tablet 5mg and matching placebos.
- Participants who have been on oral donepezil 10mg will receive a transdermal patch IPI-301 (175mg/50cm2) or Aricept tablet 10mg and matching placebos.
Participants who have not been treated with donepezil previously will receive the lower dose of investigational product (i.e., either IPI-301 (87.5mg/25cm2) or Aricept tablet 5mg and matching placebo) for 6 weeks, and then will be increased to the higher dose (i.e., IPI-301 (175mg/50cm2) or Aricept tablet 10mg and matching placebo) if they have not experienced any severe side effects.
The whole study period lasts about 30 weeks. There will be a screening period of up to 2 weeks, treatment period of 24 weeks. During the treatment period, study visits will be performed every 6 weeks, with the end-of-treatment visit on Week 24 of treatment and one safety follow-up visit on week 28. The transdermal patch test drug or its placebo will be attached to an area on the back. The patch has to be replaced twice a week (at an interval of 3 or 4 days) before going to bed. When replacing a patch the previously attached patch has to be removed. Under circumstances where application before going to bed is not feasible, it can be done at a suitable time which then should be followed at every application of the patch.

The participant must have a reliable caregiver who regularly contacts the participant and is available to accompany the participant for on-site visits. The caregiver must be able to oversee the participant's compliance with the study treatment, help the participant to attach and remove the patch from their back and to report on the participant's status.
Intervention code [1] 298376 0
Treatment: Drugs
Comparator / control treatment
Comparator will be 5mg or 10mg Aricept (Donepezil) film-coated, round tablets or its matching placebo taken orally once daily before going to bed for 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 302463 0
Changes in Alzheimer's Disease Assessment Scale-Cognitive subscale.
Timepoint [1] 302463 0
Assessed at baseline and week 24
Primary outcome [2] 302464 0
Clinician's Interview-Based Impression of Change Plus Caregiver Input
Timepoint [2] 302464 0
At week 24.
Secondary outcome [1] 336076 0
Changes in Mini-Mental State Examination
Timepoint [1] 336076 0
Assess at screening and week 24.

Eligibility
Key inclusion criteria
1) Age between 50 and 85 years (inclusive)
2) Clinical diagnosis of probable Alzheimer’s disease according to DSM-IV and NINCDS-ADRDA
3) Mini Mental Status Examination (MMSE) score great then or equal to 10 or less then or equal 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 participant must have a reliable caregiver who regularly contacts the participant subject and is available to accompany the participant for on-site visits.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Possible, probable, or definite vascular dementia according to NINDS-AIREN
2) History and/or evidence 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
3) Treatment with other anti-dementia drugs (galantamine, memantine, rivastigmine, tacrine), Except donepezil, within the past 3 months.
4) 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.)
5) 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
6) Diagnosis of serious mental disease based on DSM-5 criteria, including depressive disorder, schizophrenia, alcoholism, drug dependency, etc
7) Parkinson’s disease or parkinsonian syndrome
8) Clinically significant ECG abnormalities (heart rate <50 beats/min, atrial and ventricular conduction disorders such as 2nd degree atrioventricular block, QTc interval>480ms
9) History of unstable angina pectoris, myocardial infarction, transient ischemic attack, or coronary intervention including coronary bypass within the past 6 months
10) History of severe traumatic head injury with loss of consciousness within the past 6 months
11) Asthma or obstructive pulmonary disease requiring medication
12) Uncontrolled diabetes mellitus
13) Hypersensitivity reactions to donepezil HCl or piperidine derivatives
14) Pregnant or lactating woman or woman of childbearing potential who does not agree to use an effective method of contraception
15) Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2017
Actual
11/10/2017
Date of last participant enrolment
Anticipated
31/10/2018
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
588
Accrual to date
112
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 8383 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 8384 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 8385 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 8387 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 9126 0
Caulfield Hospital - Caulfield
Recruitment hospital [6] 9127 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 9128 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment postcode(s) [1] 16455 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 16456 0
2077 - Hornsby
Recruitment postcode(s) [3] 16457 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 16459 0
3084 - Heidelberg
Recruitment postcode(s) [5] 17633 0
3162 - Caulfield
Recruitment postcode(s) [6] 17634 0
2298 - Waratah
Recruitment postcode(s) [7] 17635 0
2113 - Macquarie Park
Recruitment outside Australia
Country [1] 8990 0
Taiwan, Province Of China
State/province [1] 8990 0
Country [2] 8991 0
Malaysia
State/province [2] 8991 0
Country [3] 8992 0
Korea, Republic Of
State/province [3] 8992 0

Funding & Sponsors
Funding source category [1] 296756 0
Commercial sector/Industry
Name [1] 296756 0
ICURE Pharmaceutical Inc.
Country [1] 296756 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Clinipace Australia Pty Ltd
Address
38 Bligh St, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 295737 0
None
Name [1] 295737 0
Address [1] 295737 0
Country [1] 295737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297981 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297981 0
Ethics committee country [1] 297981 0
Australia
Date submitted for ethics approval [1] 297981 0
21/06/2017
Approval date [1] 297981 0
18/12/2017
Ethics approval number [1] 297981 0
RESP/17/192
Ethics committee name [2] 297983 0
Bellberry Human Research Ethics Committee
Ethics committee address [2] 297983 0
Ethics committee country [2] 297983 0
Australia
Date submitted for ethics approval [2] 297983 0
14/09/2017
Approval date [2] 297983 0
23/11/2017
Ethics approval number [2] 297983 0
2017-07-495-A-1
Ethics committee name [3] 300323 0
Konkuk University Medical Center IRB
Ethics committee address [3] 300323 0
Ethics committee country [3] 300323 0
Korea, Republic Of
Date submitted for ethics approval [3] 300323 0
21/07/2017
Approval date [3] 300323 0
03/08/2017
Ethics approval number [3] 300323 0
KUHS 0397-066

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75650 0
Prof Susan Kurrle
Address 75650 0
Hornsby Ku-ring-Gai Hospital
RACS Research Unit
Old Leighton Lodge
Gate 6
Derby Road
Hornsby , NSW 2077
Country 75650 0
Australia
Phone 75650 0
+61 2 9477 9245
Fax 75650 0
Email 75650 0
Sue.Kurrle@health.nsw.gov.au
Contact person for public queries
Name 75651 0
Jandee Kim
Address 75651 0
Icure Pharmaceutical Inc, 5F, Sehyun Bld., 7, Saimdang-ro 1-gil, Seocho-gu, 06649 Seoul
Country 75651 0
Korea, Republic Of
Phone 75651 0
+82-6959-6909 (ext. 236)
Fax 75651 0
+82-2-586-8580
Email 75651 0
jdkim@icure.co.kr
Contact person for scientific queries
Name 75652 0
Yong-Jin Kim
Address 75652 0
Icure Pharmaceutical Inc, 5F, Sehyun Bld., 7, Saimdang-ro 1-gil, Seocho-gu, 06649 Seoul
Country 75652 0
Korea, Republic Of
Phone 75652 0
+82-6959-6909 (ext. 235)
Fax 75652 0
+82-2-586-8580
Email 75652 0
yjkim2@icure.co.kr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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