- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855686
Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
September 19, 2013 updated by: H. Lundbeck A/S
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
The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period.
This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.
Study Type
Interventional
Enrollment (Actual)
199
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Munich, Germany, 80804
- DE001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Daily oral dose
|
EXPERIMENTAL: Memantine
|
20mg once daily oral dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 3, 2009
First Posted (ESTIMATE)
March 4, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 20, 2013
Last Update Submitted That Met QC Criteria
September 19, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Parkinson Disease
- Dementia
- Alzheimer Disease
- Lewy Body Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- 11018
- 2005-002038-36 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia With Lewy Bodies
-
EIP Pharma IncWorldwide Clinical TrialsCompletedDementia With Lewy Bodies (DLB)United States, Netherlands
-
Osaka UniversityCompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.CompletedDementias With Lewy BodiesUnited States
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
University Hospital, Strasbourg, FranceRecruitingDementia With Lewy Bodies Diagnosis | Significant Cognitive Fluctuations in DLBFrance
-
Eisai Co., Ltd.Completed
-
CND Life SciencesNational Institute on Aging (NIA)RecruitingMCI-AD, Early Stage Alzheimer's Disease | MCI-DLB, Early Stage Dementia With Lewy BodiesUnited States
-
Cognition TherapeuticsNational Institute on Aging (NIA)RecruitingDementia With Lewy BodiesUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States