Clinical trial NCT00230568: EARTH 413: A Study of Aricept in Hispanic Patients With Mild to Moderate Alzheimer's Disease (AD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Mild to Moderate Alzheimer's Disease
Hispanic
Latino
Spanish-speaking
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: FOME (Fuld Object Memory Evaluation); SDMT (Symbol Digit Modalities Test); NPI (Neuropsychiatric Inventory); MMSE (the Mini-Mental State Examination).
timeFrame: 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: Alzheimer's Disease and Cognitive Disorders Clinic at Barrow Neurology Institute
state: Arizona
city: El Centro
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease Movement Disorders Center - Boca Raton
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Miami
country: United States
facility: Cuervo Research Group
state: Florida
city: Miami
country: United States
facility: Seth Hochman, MD
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Neurodiagnostic Center
state: Florida
city: Pompano Beach
country: United States
facility: Memory Disorder Center
state: Florida
city: Port Charlotte
country: United States
facility: Liliana Montoya, MD
state: Florida
city: Tampa
country: United States
facility: Roskamp Institute Memory Clinic
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: The Northwestern Alzheimer's Center
state: Illinois
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Joliet
country: United States
facility: Lozano, Cosme, MD
state: Illinois
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine,
state: Nevada
city: Kenilworth
country: United States
facility: ClinSearch Inc.
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine, Department of Psychiatry
state: New Mexico
city: New York
country: United States
facility: New York University School of Medicine, Aging and Dementia Research Center
state: New York
city: White Plains
country: United States
facility: The Burke Rehabilitation Hospital
state: New York
city: Charlotte
country: United States
facility: North Carolina Neuropsychiatry, PA
state: North Carolina
city: Oklahoma City
country: United States
facility: Clinical Research Associates, Inc.
state: Oklahoma
city: Jenkintown
country: United States
facility: Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Penn Ralston Center, University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Mental Sciences Insitute
state: Texas
city: San Antonio
country: United States
facility: Christopher Ticknor, MD
state: Texas
city: San Antonio
country: United States
facility: University of Texas, Health Science Center-San Antonio
state: Texas
Study officials:
affiliation: Eisai Inc.
name: James Prodafikas
role: STUDY_DIRECTOR
References: