EARTH 413: A Study of Aricept in Hispanic Patients With Mild to Moderate Alzheimer's Disease (AD)

Alzheimer's Disease Clinical Trial

Official title:

A 12-Week, Multicenter, Open-Label Study to Evaluate the Effectiveness and Safety of Donepezil Hydrochloride (Aricept) in Hispanic Patients With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230568
• Other study ID #: E2020-A001-413
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2005
• Last updated: March 31, 2011
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

12-week, open-label study to evaluate the effectiveness and safety of donepezil hydrochloride in Hispanic patients with mild to moderate Alzheimer's Disease (AD) in the U.S.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

INCLUSION CRITERIA:

• Patients who self-identify as Hispanic and currently live in the United States.

• Age range: Patients >= 50 years.

• Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile.

• MMSE scores between 10 and 26 (inclusive).

• Patients must have diagnostic evidence of AD (DSM-IV and NINCDS/ADRDA criteria) either prior to or at the screening visit. Patients with AD who may also have cerebrovascular disease as evidenced by risk factors such as hypertension, diabetes, elevated cholesterol levels, and smoking are also eligible to enroll in the study. In order to be enrolled, such patients' clinical conditions must be controlled, and it must be the investigator's opinion that the patient's primary diagnosis is AD, not vascular dementia. The diagnosis of AD must be recorded in the patient's clinical record prior to the baseline visit.

• CT or MRI within the last 12 months consistent with a diagnosis of AD without any other clinically significant comorbid pathologies found. Patients with vascular changes may be included provided that they do not meet NINDS-AIREN criteria for probable Vascular Dementia (VaD). A copy of the report will be required and should be appended to the case report form. 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.

• All patients must be naïve to Aricept® treatment. Previous use of an approved or unapproved cholinesterase inhibitor (Exelon® , Cognex®, Reminyl®/Razadyne®, metrifonate, physostigmine) or memantine is allowed provided that the medication was discontinued at least 3 months prior to screening and that the discontinuation was not done for the purpose of enrolling the patient in this trial.

• Patients must reside in the community. (Residence in an assisted living facility is allowed.)

• Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule. The caregiver must have a minimum of three days per week of direct contact with the patient (for at least 4 hours per day during waking hours).

• The patient must be capable of reliably completing study assessments including all efficacy parameters (MMSE, SDMT, and FOME) and all procedures scheduled during the screening, baseline and all follow-up visits.

• Patients 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.

• Patients with stable insulin-dependent diabetes or diabetes stabilized by diet and/or oral hypoglycemic agents are eligible provided they are monitored regularly to ensure adequacy of control. Patients with known diabetes should have an HbA1c of < 8% at screening.

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

• Patients 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, and the stable treatment is maintained throughout study.

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

• Patients must be able to swallow tablet medication -- no crushing of the tablet is allowed.

• Patient must be ambulatory or ambulatory-aided (i.e., walker or cane, or wheelchair). His/her vision and hearing (eyeglasses and/or hearing aid permissible) must be sufficient for compliance with testing procedures.

EXCLUSION CRITERIA:

• Age range: Patients < 50 years.

• MMSE score of < 10 or > 26.

• Patients 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).

• Patients with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.

• Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.

• Patients who live in a skilled nursing facility (nursing home) or expect to enter nursing home within the next 3 months.

• Patients with clinically significant obstructive pulmonary disease or asthma not controlled with treatment at any time during the previous 3 months.

• Patients with recent (< 2 years) hematological/oncological disorders.

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

• Patients with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than AD (as per DSM-lV).

• Patients with dementia complicated by delirium (DSM 290.30 or 290.11); depression or delusions are common in AD, and patients with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.

• Patients with a known or suspected history of alcoholism or drug abuse (within the past 5 years).

• Patients 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.

• Patients 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 T-4 and TSH at screening.

• Patients with diabetes mellitus controlled by diet, oral medication, or insulin who do not have an HbA1c of < 8.0% and a random serum glucose value of < 170 mg/dl.

• Patients previously treated with Aricept® (donepezil Hydrochloride).

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Aricept

Locations

Country	Name	City	State
United States	University of New Mexico School of Medicine, Department of Psychiatry	Albuquerque	New Mexico
United States	Parkinson's Disease Movement Disorders Center - Boca Raton	Boca Raton	Florida
United States	Bradenton Research Center	Bradenton	Florida
United States	North Carolina Neuropsychiatry, PA	Charlotte	North Carolina
United States	Rush Alzheimer's Disease Center	Chicago	Illinois
United States	The Northwestern Alzheimer's Center	Chicago	Illinois
United States	Pacific Sleep Medicine Services, Inc.	El Centro	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Berma Research Group	Hialeah	Florida
United States	Eastern Research	Hialeah	Florida
United States	University of Texas Mental Sciences Insitute	Houston	Texas
United States	Clinical Research Center	Jenkintown	Pennsylvania
United States	Lozano, Cosme, MD	Joliet	Illinois
United States	ClinSearch Inc.	Kenilworth	New Jersey
United States	University of Nevada School of Medicine,	Las Vegas	Nevada
United States	Pacific Sleep Medicine Services, Inc.	Los Angeles	California
United States	Cuervo Research Group	Miami	Florida
United States	Seth Hochman, MD	Miami	Florida
United States	Collier Neurologic Specialists	Naples	Florida
United States	New York University School of Medicine, Aging and Dementia Research Center	New York	New York
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Ocala Neurodiagnostic Center	Ocala	Florida
United States	Clinical Research Associates, Inc.	Oklahoma City	Oklahoma
United States	The Penn Ralston Center, University of Pennsylvania	Philadelphia	Pennsylvania
United States	21st Century Neurology	Phoenix	Arizona
United States	Alzheimer's Disease and Cognitive Disorders Clinic at Barrow Neurology Institute	Phoenix	Arizona
United States	Memory Disorder Center	Pompano Beach	Florida
United States	Liliana Montoya, MD	Port Charlotte	Florida
United States	Christopher Ticknor, MD	San Antonio	Texas
United States	University of Texas, Health Science Center-San Antonio	San Antonio	Texas
United States	Pacific Sleep Medicine Services, Inc.	San Diego	California
United States	Roskamp Institute Memory Clinic	Tampa	Florida
United States	Palm Beach Neurology	West Palm Beach	Florida
United States	Cleveland Clinic Florida	Weston	Florida
United States	The Burke Rehabilitation Hospital	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FOME (Fuld Object Memory Evaluation); SDMT (Symbol Digit Modalities Test); NPI (Neuropsychiatric Inventory); MMSE (the Mini-Mental State Examination).		12 weeks.	No