The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility

NCT00571064

Last updated date
Study Location
Senior Care
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mild to Severe Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Age range: Subjects > 50 years of age.

2. Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile. Women of child bearing potential (< 1 year post menopausal) must be practicing effective contraception and have a negative ß-hCG at screening (Women who are breast feeding are excluded).

3. MMSE scores between 5 and 24 (inclusive).

4. Subjects must have diagnostic evidence of possible or probable AD either prior to or at the screening visit based on Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke criteria.

5. CT or MRI within the last 12 months consistent with a diagnosis of AD without any other clinically significant comorbid pathologies found. A copy of the report will be required and will be collected. If there has been a significant change in clinical status suggestive of stroke or other neurological disease in addition to AD with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated during screening.

6. The caregiver/ informant can be a family member or a professional and must have had contact with the subject at least 6 Weeks prior to study entry and spent at minimum 3 days a Week (10 hours per Week) with the subject. For study visit, the subject can be seen at the Assisted Living Facility (ALF) or in the clinic setting of the Investigator. At each visit, the caregiver/informant will provide the information for completion of the safety and efficacy assessments based on knowledge of and time spent with the subject.

7. Subjects must reside in an ALF.

8. The subject is expected to complete all procedures scheduled during the screening, baseline, interim, and final visits including all efficacy assessments.

9. Putative non-prescription/prescription cognitive enhancers (e.g. ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs [NSAIDs]) will not be excluded but will be discouraged. If a putative cognitive enhancer is present, the dosage must have been stable for at least 3 months prior to the screening visit and should not change during the course of the study.

10. Subjects with controlled hypertension (sitting diastolic BP < 95 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.

11. Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.

12. Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months prior to screening and have not had a seizure within the past 6 months.

13. Subjects must be able to swallow tablet medication -- no crushing of tablet is allowed.

14. Health: independent or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for compliance with testing procedures.

15. Subjects must be sufficiently proficient in the language in which the assessments are to be conducted.

16. Subjects must have clinical laboratory values within normal limits, and within the Eisai (sponsor) guidelines, or abnormalities considered not clinically significant by the investigator and sponsor.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Age range: Subjects < 50 years of age.


2. MMSE score of ≤4 or ≥25.


3. Subjects with active or clinically significant conditions affecting absorption,
distribution or metabolism of the study medication (e.g., inflammatory bowel disease,
gastric or duodenal ulcers or severe lactose intolerance).


4. Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase
inhibitors.


5. Subjects living in a skilled nursing home or subjects living in an ALF who may be
moved to a skilled nursing home during the course of the study. Subjects who transfer
from an ALF to a skilled nursing home during this study will be discontinued.


6. Subjects who have taken the following medications within the last 3 months prior to
screening will be not eligible: Aricept, Exelon, Cognex, Razadyne, Metrifonate,
Namenda or propentofylline.


7. Subjects without a reliable caregiver/informant or subjects whose caregiver is
unwilling or unable to complete the outcome measures and fulfill the requirements of
this study.


8. Subjects with clinically significant obstructive pulmonary disease or asthma,
untreated for > 3 months.


9. Subjects with recent (< 2 years) hematologic/ oncologic disorders, not including mild
anemia or basal or squamous cell carcinoma of the skin. Subjects with current evidence
of malignant neoplasm or recurrent or metastatic disease will be excluded.


10. Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine
or cardiovascular system disease.


11. Subject with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any
current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-lV).


12. Subjects with dementia complicated by other organic disease (DSM 290.30 or 290.11) are
excluded; depression or delusions are common in Alzheimer's disease, and subjects with
severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis,
are excluded.


13. Subjects with a known or suspected history of alcoholism or drug abuse (within the
past 10 years).


14. Subjects with treated hypothyroidism that have not been on a stable dose of medication
for 3 months prior to screening and who do not have normal serum Free T3, Free T4 and
TSH at screening.


15. Subjects with treated vitamin B-12 deficiency who have not been on a stable dose of
medication for at least 3 months prior to the study screening visit and who do not
have normal serum B-12 levels at screening.


16. Any subject taking a prohibited medication will be excluded.


17. Any condition which would make the subject or the caregiver, in the opinion of the
investigator, unsuitable for the study.

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Mild to Severe Alzheimer's DiseaseThe Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
NCT00571064
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Anaheim, California
  5. Carson, California
  6. Fresno, California
  7. Hawthorne, California
  8. Santa Ana, California
  9. Danbury, Connecticut
  10. Norwalk, Connecticut
  11. Miami Springs, Florida
  12. Miami, Florida
  13. Orlando, Florida
  14. Tampa, Florida
  15. Tampa, Florida
  16. Venice, Florida
  17. Chicago, Illinois
  18. Elk Grove, Illinois
  19. Indianapolis, Indiana
  20. Mission, Kansas
  21. Paducah, Kentucky
  22. Belmont, Massachusetts
  23. Pittsfield, Massachusetts
  24. Las Vegas, Nevada
  25. Toms River, New Jersey
  26. Albuquerque, New Mexico
  27. Albany, New York
  28. Buffalo, New York
  29. Rochester, New York
  30. Centerville, Ohio
  31. Oklahoma City, Oklahoma
  32. Philadelphia, Pennsylvania
  33. East Providence, Rhode Island
  34. East Providence, Rhode Island
  35. Austin, Texas
  36. Plano, Texas
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
Official Title  ICMJE A 12-Week, Multicenter, Open Label Study To Evaluate The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
Brief Summary This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mild to Severe Alzheimer's Disease
Intervention  ICMJE Drug: Donepezil HCl
One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.
Other Name: Aricept
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Donepezil HCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2013)
97
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2007)
100
Actual Study Completion Date  ICMJE April 22, 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age range: Subjects > 50 years of age.
  2. Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile. Women of child bearing potential (< 1 year post menopausal) must be practicing effective contraception and have a negative ß-hCG at screening (Women who are breast feeding are excluded).
  3. MMSE scores between 5 and 24 (inclusive).
  4. Subjects must have diagnostic evidence of possible or probable AD either prior to or at the screening visit based on Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke criteria.
  5. CT or MRI within the last 12 months consistent with a diagnosis of AD without any other clinically significant comorbid pathologies found. A copy of the report will be required and will be collected. If there has been a significant change in clinical status suggestive of stroke or other neurological disease in addition to AD with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated during screening.
  6. The caregiver/ informant can be a family member or a professional and must have had contact with the subject at least 6 Weeks prior to study entry and spent at minimum 3 days a Week (10 hours per Week) with the subject. For study visit, the subject can be seen at the Assisted Living Facility (ALF) or in the clinic setting of the Investigator. At each visit, the caregiver/informant will provide the information for completion of the safety and efficacy assessments based on knowledge of and time spent with the subject.
  7. Subjects must reside in an ALF.
  8. The subject is expected to complete all procedures scheduled during the screening, baseline, interim, and final visits including all efficacy assessments.
  9. Putative non-prescription/prescription cognitive enhancers (e.g. ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs [NSAIDs]) will not be excluded but will be discouraged. If a putative cognitive enhancer is present, the dosage must have been stable for at least 3 months prior to the screening visit and should not change during the course of the study.
  10. Subjects with controlled hypertension (sitting diastolic BP < 95 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
  11. Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.
  12. Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months prior to screening and have not had a seizure within the past 6 months.
  13. Subjects must be able to swallow tablet medication -- no crushing of tablet is allowed.
  14. Health: independent or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for compliance with testing procedures.
  15. Subjects must be sufficiently proficient in the language in which the assessments are to be conducted.
  16. Subjects must have clinical laboratory values within normal limits, and within the Eisai (sponsor) guidelines, or abnormalities considered not clinically significant by the investigator and sponsor.

Exclusion Criteria:

  1. Age range: Subjects < 50 years of age.
  2. MMSE score of ?4 or ?25.
  3. Subjects with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance).
  4. Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
  5. Subjects living in a skilled nursing home or subjects living in an ALF who may be moved to a skilled nursing home during the course of the study. Subjects who transfer from an ALF to a skilled nursing home during this study will be discontinued.
  6. Subjects who have taken the following medications within the last 3 months prior to screening will be not eligible: Aricept, Exelon, Cognex, Razadyne, Metrifonate, Namenda or propentofylline.
  7. Subjects without a reliable caregiver/informant or subjects whose caregiver is unwilling or unable to complete the outcome measures and fulfill the requirements of this study.
  8. Subjects with clinically significant obstructive pulmonary disease or asthma, untreated for > 3 months.
  9. Subjects with recent (< 2 years) hematologic/ oncologic disorders, not including mild anemia or basal or squamous cell carcinoma of the skin. Subjects with current evidence of malignant neoplasm or recurrent or metastatic disease will be excluded.
  10. Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
  11. Subject with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-lV).
  12. Subjects with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depression or delusions are common in Alzheimer's disease, and subjects with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
  13. Subjects with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
  14. Subjects with treated hypothyroidism that have not been on a stable dose of medication for 3 months prior to screening and who do not have normal serum Free T3, Free T4 and TSH at screening.
  15. Subjects with treated vitamin B-12 deficiency who have not been on a stable dose of medication for at least 3 months prior to the study screening visit and who do not have normal serum B-12 levels at screening.
  16. Any subject taking a prohibited medication will be excluded.
  17. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571064
Other Study ID Numbers  ICMJE E2020-A001-415
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:James Prodafikas, MDEisai Inc.
PRS Account Eisai Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP