Open Label Extension Study of 23 mg Donepezil SR in Patients with Moderate to Severe Alzheimer's Disease.
- Conditions
- Alzheimer's DiseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2006-004890-93-LT
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1450
Inclusion Criteria for Patients
1) Written informed consent will be obtained from the patient (if possible) or from the patient’s legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study and the record should note this assent.
2) Completion of study E2020-G000-326, including the SIB and the ADCS-ADL
at the Final Visit. Refusal of patients to take either of these tests will disqualify them from entry into study E2020-G000-328.
3) There must be no ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 in its entirety.
4) Patients must enroll in the present study within 3 days of completion of study
E2020-G000-326.
5) Health: physically healthy and ambulatory or ambulatory-aided (i.e., walker or cane); corrected vision and hearing sufficient for compliance with testing procedures.
6) Co-morbid medical conditions must be well-controlled as determined by the
investigator.
7) Patients undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) at doses that are less than or equal to the approved dose range of therapeutic efficacy as specified in the Physician’s Desk Reference or equivalent may enter the study.
8) Concomitant Medications: Patients undergoing treatment with the following
medications may be enrolled in the study provided the following conditions are met.
a. Chronic daily benzodiazepine use may be allowed if doses are stable within an approved dose range consistent with currently accepted standards of practice, to be confirmed by Medical Monitor. Chronic intermittent use of benzodiazepines may be allowed pending consultation and approval by the Medical Monitor but not within 48 hours of scheduled assessment.
b. Bronchodilator medications for treatment of COPD may be allowed as long as
drug is administered via metered dose inhaler within approved dose range.
c. Memantine is allowed if taken at doses of 20 mg/day or less (as specified in
the Physician’s Desk Reference or equivalent), provided that the dose is stable.
9) The patient must have a relative/caregiver who supervises the regular taking of the drug at the correct dose and is alert for possible side effects, unless the patient’s legal guardian takes on this task
Inclusion Criteria for Caregivers
Written informed consent will be obtained from the designated caregiver for participation in study assessments. The caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. Specifically, the caregiver must have sufficient contact with the patient to provide accurate reports of the patient’s functioning, must be able to observe for possible adverse events, and must be able to accompany the patient to all visits. It is preferable that the caregiver be the same as in study E2020-G000-326. If no replacement caregiver is available who meets the caregiver inclusion/exclusion criteria, the patient must be discontinued from the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria for Patients
1) No caregiver available to meet the inclusion criteria for caregivers.
2) Patients with any active or clinically-significant conditions affecting
absorption, distribution, or metabolism of the study medication (e.g., inflammatory
bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose
intolerance).
3) Known plan for elective surgery during the study period that would require
general anesthesia and administration of neuromuscular blocking agents, such as
succinylcholine, to induce paralysis/muscle relaxation. Minor surgery, such as
colonoscopy or cataract surgery, will be permitted as long as it does not require the
use of these paralytic agents.
4) Patients who are unwilling or unable to fulfill the requirements of the study.
5) Use of any prohibited prior or concomitant medications as described in
Section 10.7 and listed in Appendix 4.
6) Any condition that would make the patient, in the opinion of the investigator,
unsuitable for the study.
7) Patients taking concomitant antidepressant medication known to have
significant anticholinergic effects, such as tricyclic antidepressants prescribed at doses recommended for the treatment of major depression. Prohibited antidepressants are listed in Appendix 4 of the protocol.
8) Patients who cannot swallow or who have difficulty swallowing whole tablets.
9) Patients taking any alternative medication such as vitamins and/or herbal products or alternative medical techniques such as acupuncture or acupressure specifically for the treatment of AD are not eligible.
Exclusion Criteria for Caregivers
1) Caregivers who are unwilling or unable to give informed consent or otherwise to
fulfill the requirements of the study.
2) Any condition that would make the caregiver, in the opinion of the Investigator,
unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the safety and efficacy of long-term administration of 23 mg donepezil SR in patients with moderate to severe Alzheimer’s disease.;Secondary Objective: None;Primary end point(s): Efficacy Assessments:<br>Sever Impairment Battery (SIB) (cognitive function of patient), Mini Mental State Examination (MMSE) cognitive function of patient, Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) functional capabilities of patient, Quality of Life -Alzheimer's Disease (QoL-AD), and EuroQoL -5 Dimension (EQ-5D) quality of life, Screen for Caregiver Burden (SCB) non professional caregiver burden, Treatment Outcome Scale (TOS) treatment outcomes, Goal Attainment Scale (GAtS) caregiver and patient treatment goals.<br><br>Safety Assessments:<br>Vital signs, weight, complete physical examination, complete or basic neurological examination, 12-lead ECG, clinical laboratory screens of blood and urine, adverse event monitoring.<br><br><br>
- Secondary Outcome Measures
Name Time Method