None listed
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch comparing to donepezil oral tablet (Aricept) in patients with mild to moderate Alzheimer’s disease.
Interventions
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)
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.
Sponsors
Clinipace Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
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.
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
Outcome results
None listed