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

NCT00230568 | Completed Phase 4

• 1 other identifier: E2020-A001-413
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 35

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.

Conditions

Alzheimer's Disease

Keywords

Mild to Moderate Alzheimer's Disease; Hispanic; Latino; Spanish-speaking

Outcome Measures

Primary Outcomes (1)

• FOME (Fuld Object Memory Evaluation); SDMT (Symbol Digit Modalities Test); NPI (Neuropsychiatric Inventory); MMSE (the Mini-Mental State Examination).

  12 weeks.

Interventions

Aricept DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Pfizer: collaborator

Study Sites (35)

21st Century Neurology

Phoenix, Arizona, 85013, United States

Location

Alzheimer's Disease and Cognitive Disorders Clinic at Barrow Neurology Institute

Phoenix, Arizona, 85013, United States

Location

Pacific Sleep Medicine Services, Inc.

El Centro, California, 92243, United States

Location

Pacific Sleep Medicine Services, Inc.

Los Angeles, California, 90048, United States

Location

Pacific Sleep Medicine Services, Inc.

San Diego, California, 92121, United States

Location

Parkinson's Disease Movement Disorders Center - Boca Raton

Boca Raton, Florida, 33486, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Eastern Research

Hialeah, Florida, 33013, United States

Location

Berma Research Group

Hialeah, Florida, 33016, United States

Location

Cuervo Research Group

Miami, Florida, 33143, United States

Location

Seth Hochman, MD

Miami, Florida, 33156, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Ocala Neurodiagnostic Center

Ocala, Florida, 34471, United States

Location

Memory Disorder Center

Pompano Beach, Florida, 33064, United States

Location

Liliana Montoya, MD

Port Charlotte, Florida, 33952, United States

Location

Roskamp Institute Memory Clinic

Tampa, Florida, 33617, United States

Location

Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

The Northwestern Alzheimer's Center

Chicago, Illinois, 60611, United States

Location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

Lozano, Cosme, MD

Joliet, Illinois, 60435, United States

Location

University of Nevada School of Medicine,

Las Vegas, Nevada, 89102, United States

Location

ClinSearch Inc.

Kenilworth, New Jersey, 07033, United States

Location

University of New Mexico School of Medicine, Department of Psychiatry

Albuquerque, New Mexico, 87131, United States

Location

New York University School of Medicine, Aging and Dementia Research Center

New York, New York, 10016, United States

Location

The Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

North Carolina Neuropsychiatry, PA

Charlotte, North Carolina, 28209, United States

Location

Clinical Research Associates, Inc.

Oklahoma City, Oklahoma, 73118, United States

Location

Clinical Research Center

Jenkintown, Pennsylvania, 19046, United States

Location

The Penn Ralston Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Mental Sciences Insitute

Houston, Texas, 77030, United States

Location

Christopher Ticknor, MD

San Antonio, Texas, 78229, United States

Location

University of Texas, Health Science Center-San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• James Prodafikas

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: October 3, 2005
• Study Start: December 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 1, 2011

Record last verified: 2011-03

Locations

US (35)