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Open-Label Extension Study of 23mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease

This study is not yet open for participant recruitment.
Verified by Eisai Medical Research Inc., November 2007

Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00566501
  Purpose

Patients who complete study E2020-G000-326 with no ongoing SAEs and no serious adverse drug reactions during this doubleblind study will be eligible to enter the open-label extension study.


Condition Intervention Phase
Alzheimer's Disease
Drug: Aricept
Phase III

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease   

Drug Information available for:   Donepezil    E 2020   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Open-Label Extension Study of 23mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • SIB, MMSE, ADCS-ADL, QoL-AD and EQ-5D (quality of life), TOS (treatment outcomes), GAtS [ Time Frame: Every 3 months (+/- 5 days). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vital signs, weight, complete physical examination, basic neurological examination. [ Time Frame: Every 3 months (+/- 5 days). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   1600
Study Start Date:   December 2007
Estimated Study Completion Date:   August 2010

Arms Assigned Interventions
1: Active Comparator Drug: Aricept
1 tablet, 23 mg, once a day.

  Eligibility
Ages Eligible for Study:   45 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  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. Age range: Adult patients, 45 to 91 years of age inclusive.
  3. Completion of study E2020-G000-326 with no ongoing SAEs or history of serious adverse drug reactions during this study in its entirety.

    Patients must enroll in the present study within 7 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. Clinical laboratory values must be within normal limits or, if abnormal, must be judged not clinically significant by the investigator.
  6. Patients with risk factors of hypertension and cardiac disease may be enrolled in the study, provided that hypertension is medication controlled (supine diastolic BP < 95 mm Hg) and cardiac disease (eg, angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias) is stable on appropriate medication for 3 months prior to Baseline. Peripheral vascular disease must also have been stable for 3 months prior to Baseline.
  7. Patients with diabetes mellitus or risk factors for diabetes mellitus may be enrolled in the study provided that the patient's disease is stable and that there have been no recent (within 3 months) hospitalizations for diabetic ketoacidosis, hyperosmolar coma, or hypoglycemia. Patients with non-insulin-dependent diabetes may enroll in the study if controlled on diet or oral medications.
  8. All diabetic patients must have an HbA1c concentration of < 10% and a fasting (8 hours) serum glucose concentration of < 170 mg/dL, or a random serum glucose concentration of < 250 mg/dL at Baseline.
  9. Patients undergoing treatment with selective serotonin re-uptake inhibitors (SSRI) (≤ 10 mg daily of escitalopram, ≤ 20 mg daily of citalopram or fluoxetine, ≤ 30 mg daily of paroxetine, < 50 mg daily of sertraline or ≤ 100 mg daily of fluvoxamine) may enter the study provided that the SSRI dose has been stable for at least three months prior to Baseline.

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:

  1. No caregiver available to meet the inclusion criteria for caregivers
  2. Patients with psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression. Patients with clinically-significant sleep disorders will also be excluded unless these are controlled by treatment and clinically stable for > 3 months.
  3. Patients with dementia complicated by other organic disease or Alzheimer's disease with delirium (DSM IV 290.30 or 290.11; Appendix 5)
  4. Patients with any active or clinically-significant conditions affecting absorption, distribution, or metabolism of the study medication (eg, inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance)
  5. Patients with evidence of clinically significant, active gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease
  6. Patients with current evidence of malignant neoplasms (does not include basal or squamous cell carcinoma of the skin). Males with localized prostate cancer requiring no treatment would not be excluded.
  7. 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.
  8. Patients who are unwilling or unable to fulfill the requirements of the study
  9. Use of any prohibited prior or concomitant medications
  10. Any condition that would make the patient, in the opinion of the investigator, unsuitable for the study
  11. 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.
  12. Patients who cannot swallow or who have difficult swallowing whole tablets

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566501

Contacts
Contact: Eisai Medical Services     1-888-422-4743    

Locations
United States, California
Apex Research Institute    
      Santa Ana, California, United States, 92705

Sponsors and Collaborators
Eisai Medical Research Inc.

Investigators
Study Director:     Margaret Moline, Ph.D     Eisai Medical Research Inc.    
  More Information


Responsible Party:   Eisai Medical Research Inc. ( Margaret Moline, Ph.D, Study Director )
Study ID Numbers:   E2020-G000-328
First Received:   November 29, 2007
Last Updated:   November 29, 2007
ClinicalTrials.gov Identifier:   NCT00566501
Health Authority:   United States: Food and Drug Administration;   European Union: European Medicines Agency

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 30, 2008




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