Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia
This study is currently recruiting participants.
Verified by Rotman Research Institute at Baycrest, January 2008
Sponsors and Collaborators: Rotman Research Institute at Baycrest
H. Lundbeck A/S
Information provided by: Rotman Research Institute at Baycrest
ClinicalTrials.gov Identifier: NCT00594737
  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 12 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 us to gauge the effects of memantine on cortical activity levels. We hypothesize that subjects on memantine will show normalization of cortical metabolic activity.


Condition Intervention Phase
Frontotemporal Dementia
Drug: memantine hydrochloride
Phase III

MedlinePlus related topics: Dementia
Drug Information available for: Memantine Memantine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open Label Pilot Study of the Effects of Memantine Administration on FDG-PET in Frontotemporal Dementia

Further study details as provided by Rotman Research Institute at Baycrest:

Primary Outcome Measures:
  • Metabolic activity in frontal and temporal lobes. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioural inventories, UPDRS Motor scale. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: October 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: memantine hydrochloride
    memantine hydrochloride oral tablets, 10mg po bid
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • CDR < 3, as decline beyond CDR 3 or more would be difficult to track with our primary outcome measures.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594737

Contacts
Contact: Tiffany Chow, MD 416-785-2500 ext 3459 tchow@rotman-baycrest.on.ca
Contact: Morris Freedman, MD, FRCPC 416-785-2444

Locations
Canada, Ontario
Baycrest Recruiting
Toronto, Ontario, Canada, M6A 2E1
Principal Investigator: Tiffany W Chow, MD            
Sponsors and Collaborators
Rotman Research Institute at Baycrest
H. Lundbeck A/S
Investigators
Principal Investigator: Tiffany W Chow, MD Rotman Research Institute at Baycrest, University of Toronto
  More Information

PI webpage  This link exits the ClinicalTrials.gov site
PET Imaging Centre website  This link exits the ClinicalTrials.gov site
recruiting clinic website  This link exits the ClinicalTrials.gov site
Association for Frontotemporal Dementias  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Rotman Research Institute at Baycrest, University of Toronto ( Tiffany Chow, MD, Principal Investigator )
Study ID Numbers: Baycrest.Ebixa.FTD-001, Lundbeck 11627A
Study First Received: January 7, 2008
Last Updated: January 7, 2008
ClinicalTrials.gov Identifier: NCT00594737  
Health Authority: Canada: Health Canada

Keywords provided by Rotman Research Institute at Baycrest:
PET
frontotemporal dementia
memantine
Pick's disease

Study placed in the following topic categories:
Excitatory Amino Acids
Pick Disease of the Brain
Speech Disorders
Frontotemporal dementia
Aphasia
Central Nervous System Diseases
Language Disorders
Brain Diseases
Aphasia, Primary Progressive
Cognition Disorders
Signs and Symptoms
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Neurologic Manifestations
Lobar atrophy of brain
Primary progressive aphasia
Dementia
Neurobehavioral Manifestations
Pick disease of the brain
Communication Disorders
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Excitatory Amino Acid Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009