Clinical trial NCT00566501 (phase 3, status: completed)
Conditions: alzheimer's disease
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: 23 mg sr in study 326, 10 mg ir in study 326
SMILES: COC1=C(OC)C=C2C(=O)C(CC3CCN(CC4=CC=CC=C4)CC3)CC2=C1
Eligibility criteria:

        Inclusion Criteria for Patients:

          1. Written informed consent 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.

          2. Completion of study E2020-G000-326 without ongoing SAEs or history of serious adverse
             drug reactions during study E2020-G000-326.

          3. Patients must enroll in the present study within 3 days of completion of study
             E2020-G000-326

          4. Health: physically healthy and ambulatory or ambulatory-aided (ie, walker or cane);
             corrected vision and hearing sufficient for compliance with testing procedures.

          5. Co-morbid medical conditions must be well-controlled as determined by the
             investigator.

          6. Patients undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) may
             be included provided that doses are within the approved dose range as specified in the
             Physician's Desk Reference or local equivalent

          7. Concomitant Medications: Patients undergoing treatment with the following medications
             may be enrolled in the study provided the following conditions are met: chronic daily
             benzodiazepine use if doses are stable within an approved dose range; bronchodilator
             medications for treatment of chronic obstructive pulmonary disease (COPD) as long as
             drug is administered via metered dose inhaler within approved dose range; memantine if
             taken at doses of 20 mg/day or less, provided that the dose is stable.

          8. 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.

        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.

          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.

          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 Alzheimer's disease.

        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.