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Trial record 74 of 332 for:    DONEPEZIL

A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT00934375
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : July 8, 2009
Last Update Posted : January 14, 2014
Sponsor:
Information provided by:
Eisai Inc.

Brief Summary:
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Aricept (donepezil hydrochloride) Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
Study Start Date : February 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: Aricept (donepezil hydrochloride)
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
Other Name: donepezil hydrochloride

Placebo Comparator: 2 Drug: placebo



Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Baseline, Week 6, Week 12 and Week 28. ]
    Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Age Range: Adult subjects (45 to 90 years of age inclusive)
  2. Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
  3. Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
  4. A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
  5. Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
  6. The subject must be expected to complete the entire study.
  7. Subjects must be sufficiently fluent in English.
  8. Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
  9. Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).

Exclusion Criteria:

  1. Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
  2. Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
  3. Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
  4. Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
  5. Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
  6. Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
  7. Subjects who may not be able to comply with the protocol.
  8. Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
  9. Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
  10. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
  11. Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).

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): NCT00934375


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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Anita Murthy Eisai Inc.

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Responsible Party: James Prodafikas, Study Director, Eisai Inc.
ClinicalTrials.gov Identifier: NCT00934375     History of Changes
Other Study ID Numbers: E2020-A001-414
First Posted: July 8, 2009    Key Record Dates
Results First Posted: July 8, 2009
Last Update Posted: January 14, 2014
Last Verified: December 2013
Keywords provided by Eisai Inc.:
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Donepezil
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents