- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00594737
Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia
An Open Label Pilot Study of the Effects of Memantine Administration on FDG-PET in Frontotemporal Dementia
Memantine has been approved for use in Alzheimer's disease. Its mechanism of action raises questions of whether it can also be effective for non-Alzheimer's dementias such as frontotemporal dementia (FTD), which currently has no disease-modifying treatment.
This is an open-label study to probe the effects of memantine in 15 outpatients diagnosed with FTD, as shown objectively by comparing PET scans performed before and after use of the medication. The specific type of PET scan, FDG-PET, allows the investigators to gauge the effects of memantine on cortical activity levels. The investigators hypothesize that subjects on memantine will show normalization of cortical metabolic activity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Ontario
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Toronto, Ontario, Canada, M6A 2E1
- Baycrest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must meet criteria for frontotemporal lobar degeneration (FTD) by Neary et al. criteria. 28 Subjects may have either the behavioural or the aphasic variant of FTD.
- Able to undergo psychometric testing.
- Must have reliable informant with daily contact with patient
- May be taking concurrent psychotropic medications, but must be on stable dosing regimen for 3 months prior to trial enrollment
- On the basis of a physical examination, medical history (including psychiatric and neurological), and results of blood chemistry carried out at screening visit, the patient in the investigator's opinion is considered healthy.
- Signed Informed Consent must be obtained from the patient or legally responsible representative and the informant prior to initiating any study specific procedures.
Exclusion Criteria:
- Complaint of recurrent or persistent dizziness or constipation
- Abnormal chemistry panel particular with respect to ruling out renal insufficiency or failure. We will exclude those patients with creatinine clearance (CLcr) < 50ml/min, per the Sakana equations for men and women.
- Angina, myocardial infarction, severe hypertension, severe cardiac arrhythmia, unstable diabetes mellitus, or new abnormalities on EKG within the past year.
- Any current malignancy, or any clinically significant hematological, endocrine, renal, hepatic, gastrointestinal or non-dementia neurological disease. If the condition has been stable for at least the past year and is judged by the investigators not to interfere with the patient's participation in the study, the patient may be included. Basal cell carcinoma is an exception.
- Non-English speaking, as cognitive tests will be in English.
- Evidence of other neurological or psychiatric disorders which preclude diagnosis of FTD (including, but not limited to, stroke, Parkinson's disease, any psychotic disorder, severe bipolar or unipolar depression) within the past year
- Current or prior history of uncontrolled seizure disorder, due to seizures reported as adverse events with memantine.
- Patients with suspected alcohol or substance abuse within last 1 year. If past history of abuse or dependence must have been abstinent for 1 year with continuing progression of dementia despite abstinence.
- Patients with active delusions or hallucinations at the time of screening.
- Female patients who are not at least two years post-menopausal or surgically sterile. Pre-menopausal women will be excluded; because almost all women are post-menopausal at the age of onset of FTD, we do not anticipate having to exclude more than one potential subject on the basis of this one exclusion criterion.
- Use of investigational drugs or participation in another investigational drug study within 3 months of screening.
- Patients who have previously been treated with memantine or have participated in an investigational study with memantine.
- Patients with history of severe drug allergy or hypersensitivity or known hypersensitivity to amantadine or memantine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic activity in frontal and temporal lobes.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavioural inventories, UPDRS Motor scale.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tiffany W Chow, MD, Rotman Research Institute at Baycrest, University of Toronto
Publications and helpful links
General Publications
- Swanberg MM. Memantine for behavioral disturbances in frontotemporal dementia: a case series. Alzheimer Dis Assoc Disord. 2007 Apr-Jun;21(2):164-6. doi: 10.1097/WAD.0b013e318047df5d.
- Chow TW, Binns MA, Freedman M, Pollock BG, Verhoeff NPG, Graff-Guerrero A. Pre- and post-memantine FDG-PET imaging in frontotemporal dementia. Am J Geriatr Psychiatry 2009;17(3 Supp 1): A73.
- Chow TW, Graff-Guerrero A, Verhoeff NP, Binns MA, Tang-Wai DF, Freedman M, Masellis M, Black SE, Wilson AA, Houle S, Pollock BG. Open-label study of the short-term effects of memantine on FDG-PET in frontotemporal dementia. Neuropsychiatr Dis Treat. 2011;7:415-24. doi: 10.2147/NDT.S22635. Epub 2011 Jul 13.
- Chow TW, Fam D, Graff-Guerrero A, Verhoeff NP, Tang-Wai DF, Masellis M, Black SE, Wilson AA, Houle S, Pollock BG. Fluorodeoxyglucose positron emission tomography in semantic dementia after 6 months of memantine: an open-label pilot study. Int J Geriatr Psychiatry. 2013 Mar;28(3):319-25. doi: 10.1002/gps.3832. Epub 2012 Jun 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- 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
- Baycrest.Ebixa.FTD-001
- Lundbeck 11627A
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.
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