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Alzheimer's DiseasePhase 4NCT00230568

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

A Phase 4 study testing Aricept in people with Alzheimer's Disease, run by Eisai Inc. at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Aricept
How many people
100 participants
Where
35 sitesUnited States
Study dates
Dec 2005to Dec 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • University of New Mexico School of Medicine, Department of Psychiatry

    Albuquerque, New Mexico, 87131

  • Parkinson's Disease Movement Disorders Center - Boca Raton

    Boca Raton, Florida, 33486

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • North Carolina Neuropsychiatry, PA

    Charlotte, North Carolina, 28209

  • The Northwestern Alzheimer's Center

    Chicago, Illinois, 60611

  • Rush Alzheimer's Disease Center

    Chicago, Illinois, 60612

  • Pacific Sleep Medicine Services, Inc.

    El Centro, California, 92243

  • MD Clinical

    Hallandale, Florida, 33009

  • Eastern Research

    Hialeah, Florida, 33013

  • Berma Research Group

    Hialeah, Florida, 33016

  • University of Texas Mental Sciences Insitute

    Houston, Texas, 77030

  • Clinical Research Center

    Jenkintown, Pennsylvania, 19046

  • Lozano, Cosme, MD

    Joliet, Illinois, 60435

  • ClinSearch Inc.

    Kenilworth, New Jersey, 07033

  • University of Nevada School of Medicine,

    Las Vegas, Nevada, 89102

  • Pacific Sleep Medicine Services, Inc.

    Los Angeles, California, 90048

  • Cuervo Research Group

    Miami, Florida, 33143

  • Seth Hochman, MD

    Miami, Florida, 33156

  • Collier Neurologic Specialists

    Naples, Florida, 34102

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

    New York, New York, 10016

  • Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • Ocala Neurodiagnostic Center

    Ocala, Florida, 34471

  • Clinical Research Associates, Inc.

    Oklahoma City, Oklahoma, 73118

  • The Penn Ralston Center, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • 21st Century Neurology

    Phoenix, Arizona, 85013

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

    Phoenix, Arizona, 85013

  • Memory Disorder Center

    Pompano Beach, Florida, 33064

  • Liliana Montoya, MD

    Port Charlotte, Florida, 33952

  • Christopher Ticknor, MD

    San Antonio, Texas, 78229

  • University of Texas, Health Science Center-San Antonio

    San Antonio, Texas, 78229

  • Pacific Sleep Medicine Services, Inc.

    San Diego, California, 92121

  • Roskamp Institute Memory Clinic

    Tampa, Florida, 33617

  • Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • The Burke Rehabilitation Hospital

    White Plains, New York, 10605

Other trials in United States

About this study

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

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.

Being tested
Aricept
Keywords
Mild to Moderate Alzheimer's Disease, Hispanic, Latino, Spanish-speaking
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AriceptDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionApr 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00230568
Sponsor's protocol ID
E2020-A001-413
Status last verified
Mar 2011
First submitted
29 Sep 2005
Last updated
1 Apr 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aricept in people with Alzheimer's Disease, run by Eisai Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FOME (Fuld Object Memory Evaluation); SDMT (Symbol Digit Modalities Test); NPI (Neuropsychiatric Inventory); MMSE (the Mini-Mental State Examination). (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00230568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.

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