Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Frontotemporal Dementia |
Drug: memantine hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Pilot Study of the Effects of Memantine Administration on FDG-PET in Frontotemporal Dementia |
- Metabolic activity in frontal and temporal lobes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Behavioural inventories, UPDRS Motor scale. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
-
Drug: memantine hydrochloride
- Ebixa
- Namenda
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, Ontario | |
| Baycrest | |
| Toronto, Ontario, Canada, M6A 2E1 | |
| Principal Investigator: | Tiffany W Chow, MD | Rotman Research Institute at Baycrest, University of Toronto |
More Information
Additional Information:
Publications:
| Responsible Party: | Tiffany Chow, MD, Senior Scientist, Assoc. Prof. University of Toronto, Rotman Research Institute at Baycrest |
| ClinicalTrials.gov Identifier: | NCT00594737 History of Changes |
| Other Study ID Numbers: | Baycrest.Ebixa.FTD-001, Lundbeck 11627A |
| Study First Received: | January 7, 2008 |
| Last Updated: | June 1, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Rotman Research Institute at Baycrest:
|
PET frontotemporal dementia memantine Pick's disease |
Additional relevant MeSH terms:
|
Frontotemporal Dementia Frontotemporal Lobar Degeneration Memantine Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders TDP-43 Proteinopathies Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases |
Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents |
ClinicalTrials.gov processed this record on May 19, 2013