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Sponsors and Collaborators: |
University of California, San Francisco Forest Laboratories |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00545974 |
The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia.
The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.
The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight
Condition | Intervention | Phase |
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Frontal Lobe Dementia Frontotemporal Lobe Dementia Semantic Dementia |
Drug: memantine Drug: Placebo pill |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia |
Estimated Enrollment: | 140 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Memantine 10mg BID
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Drug: memantine
memantine 10mg BID
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2: Placebo Comparator
Placebo condition
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Drug: Placebo pill
Placebo pill BID
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This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board, consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB will notify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interim analysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment.
Including screening and off-drug follow up, each subject will participate in the study for approximately 34 weeks.
The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation.
The targeted enrollment is 140.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment in this study:
Exclusion Criteria:
Any one of the following will exclude a subject from being enrolled into the study:
9. CT or MRI evidence of any of the following: hydrocephalus, stroke, space-occupying lesion, cerebral infection or any clinically significant CNS disease other than FTD. 10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
11. Abnormal ECG at screening judged to be clinically significant by the investigator.
12. Use of investigational drugs or participation in investigational drug study within 60 days of screening.
Contact: Mary Koestler, RN, Ph.D. | 415-476-0661 | mkoestler@memory.ucsf.edu |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Jill Shapira, R.N., Ph.D. 310-794-2550 | |
Principal Investigator: Mario Mendez, M.D. | |
University California, San Francisco | Recruiting |
San Francisco, California, United States, 94143-1207 | |
Contact: Kelly Blum, BS 415-476-0662 kblum@memory.ucsf.edu | |
Contact: Mary Koestler, RN,PhD 415-476-0661 mkoestler@memory.ucsf.edu | |
Principal Investigator: Adam L. Boxer, M.D., Ph.D. | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Dana Kistler 904-953-9680 kistler.dana@mayo.edu | |
Principal Investigator: Neill GraffRadford, M.D. | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Kristine Lipowski 312-695-2343 k-lipowski@northwestern.edu | |
Principal Investigator: Chuang-Kuo Wu, M.D. | |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Julie Dickson 317-278-4333 judickso@iupui.edu | |
Principal Investigator: Ann Marie Hake, M.D. | |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Sandeepa Sur, MA 410-502-3747 ssur3@jhmi.edu | |
Principal Investigator: Chiadi Onyike, M.D. | |
United States, Minnesota | |
Mayo Clinic - Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Nancy Haukom 507-266-8485 Haukom.Nancy@mayo.edu | |
Principal Investigator: David Knopman, M.D. | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Lynda Mules 212-305-2077 lm2538@columbia.edu | |
Principal Investigator: Karen L. Bell, M.D. | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7025 | |
Contact: Charlene Riedel-Leo, M.Ed., MSW 919-966-5039 charlenerl@neurology.unc.edu | |
Principal Investigator: Daniel I. Kaufer, M.D. | |
United States, Ohio | |
University Hospitals of Cleveland / Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44120 | |
Contact: Leon Hudson 216-844-6411 Leon.Hudson@case.edu | |
Principal Investigator: Alan Lerner, M.D. | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Lauren Massimo 215-349-8464 massimol@uphs.upenn.edu | |
Principal Investigator: Murray Grossman, M.D. |
Principal Investigator: | Adam L. Boxer, M.D., Ph.D. | University of California, San Francisco |
Principal Investigator: | Bruce Miller, M.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Adam Boxer, M.D., Ph.D. - Assistant Professor of Neurology ) |
Study ID Numbers: | NAM-53:memantineplacebo |
Study First Received: | October 16, 2007 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00545974 History of Changes |
Health Authority: | United States: Institutional Review Board |
Randomized Double-Blind Placebo-Controlled memantine Namenda Frontotemporal Dementia Semantic Dementia FTD |
ftd SD sd dementia Dementia behavioral decline cognitive decline |
Excitatory Amino Acids Pick Disease of the Brain Neurotransmitter Agents Speech Disorders Aphasia Primary Progressive Aphasia Central Nervous System Diseases Language Disorders Brain Diseases Aphasia, Primary Progressive Cognition Disorders Signs and Symptoms |
Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Frontotemporal Dementia Mental Disorders Memantine Neurologic Manifestations Dopamine Agents Dementia Neurobehavioral Manifestations Lobar Atrophy of Brain Communication Disorders Delirium |
Pick Disease of the Brain Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents Brain Diseases Aphasia, Primary Progressive Signs and Symptoms Mental Disorders Therapeutic Uses Memantine Dementia |
Neurobehavioral Manifestations Excitatory Amino Acid Antagonists Speech Disorders Aphasia Nervous System Diseases Language Disorders Central Nervous System Diseases Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Neurologic Manifestations Dopamine Agents Central Nervous System Agents Communication Disorders |