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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00855686 |
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Date of registration:
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03/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
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Scientific title:
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A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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199 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00855686 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Email contact via H. Lundbeck A/S |
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Address:
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Telephone:
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Email:
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Affiliation:
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LundbeckClinicalTrials@lundbeck.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The study population will consist of male or female outpatients at least 50 years of
age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to
UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB
consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to
accompany the patient to all clinic visits during the course of the study.
Exclusion Criteria:
- Evidence of clinically significant active disease, evidence of other neurological
disorders, and current treatment with AChEIs.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia With Lewy Bodies
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Parkinson's Disease Dementia
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Intervention(s)
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Drug: Placebo
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Drug: Memantine
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Primary Outcome(s)
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No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
[Time Frame: No]
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Secondary ID(s)
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11018
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2005-002038-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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