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A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165659
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:
Eisai Inc.

Brief Summary:

To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB** as the primary efficacy measures. Safety of E2020 will also be evaluated.

(*for overall evalution of clinical symtoms) (**for cognitive function test)


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: DONEPEZIL HYDROCHLORIDE Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 2002
Actual Primary Completion Date : May 2005





Primary Outcome Measures :
  1. Primary Outcomes: Efficacy:
  2. CIBIC plus*, SIB**
  3. (*for overall evalution of clinical symtoms)
  4. (**for cognitive function test)
  5. Safety:
  6. Adverse event, adverse drug reaction, vital sign, clinical laboratory parameter, electrocardiogram

Secondary Outcome Measures :
  1. Efficacy
  2. Behave-AD, ADCS-ADL-sev


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with diagnostics of Alzheimer's disease (AD) according to DSM-IV.
  • Patients with modified Hachinski Ischemic scale score of ≦6.
  • FAST score of ≧6 at baseline (4 weeks before starting study treatment).
  • MMSE score between 1 and 12 at baseline (4 weeks before starting study treatment).
  • Imaging diagnostics (CT, MRI, etc., within 24 months consistent with the diagnosis of AD without any other comorbid pathologies found. If a significant change in clinical status suggesting other types of dementia (except AD) is suspected between the final image diagnosis and the time of starting observation, the scan test should be repeated.
  • Patients who can comply with the requirements on concomitant drugs/therapies from the baseline phase or before.
  • Patients aged 50 years or older.
  • Outpatients. Even in the case of an outpatient or a patient attending on the outpatient-visit basis from a nursing home facility, the caregiver must be a constant and reliable informant with minimum of 3 days per week direct contact with the patient (for at least 4 hours per day on waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior and his/her ability to perform ADLs.
  • Patients who are expected to complete all procedures scheduled during the Screening and Baseline visit and who 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 treatment schedule.
  • Patients who can swallow tablets without pulverization.
  • Patients who are ambulatory at least aided (walker) and have vision and hearing necessary for compliance with testing procedures (eyeglasses and/or hearing aid permissible).
  • Patients whose representatives can sign the written informed consent.

Exclusion Criteria:

  • Patients with dementia other than AD.

    1. Patient whose imaging test shows "circumscribed cerebral lesion or multiple infarcts" which is suspected to be the responsible cause of dementia (mixed-type dementia)
    2. Patients with other types of dementia
  • Patients with a current DSM-IV diagnosis of major depressive disorder or any current serious psychiatric diagnosis othe than AD.
  • Patients without a reliable caregiver.
  • Patients who are expected to enter a nursing home facility within 6 months after starting study treatment (excluding a transient entry).
  • Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of study drugs (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or severe lactose intolerance).
  • Patients with a known hypersensitivity to a component of donepezil hydrochloride preparation or piperidine derivatives.
  • Patients complicated with a severe gastrointestinal, hepatic, renal, endocrine, or cardiovascular system disease (e.g., sick sinus syndrome, intraarterial and supraventricular conduction disorder, etc.).
  • Patients with a history of severe bronchial asthma or obstructive pulmonary disease.
  • Patients with a severe extrapyramidal disease (Parkinson's disease, Parkinson's syndrome, etc.).
  • Patients with diabetes mellitus with uncontrolled blood glucose levels (HbAlc of ≧10%).
  • Hypertension patients with uncontrolled blood pressure (diastolic blood pressure of ≧95 mmHg).
  • Patients with uncontrolled thyroid dysfunction.
  • Patients with a history of seizure or convulsion within the previous 3 months (obtaining informed consent).
  • Patients with a known or suspected history of alcohoism or drug dependence within the recent 10 years.
  • Patients with malignant tumors.
  • Women of pregnant, possibly pregnant, or lactating.
  • Patients who have participated in another clinical study within the recent 3 months (before giving consent).
  • Any other patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165659


Locations
Show Show 65 study locations
Sponsors and Collaborators
Eisai Limited
Investigators
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Study Director: Itaru Arimoto Eisai Co., Ltd - Development Clinical Research Dept., Clinical Research Center
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ClinicalTrials.gov Identifier: NCT00165659    
Other Study ID Numbers: E2020-J081-231
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents