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Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Tiffany Chow, MD, Rotman Research Institute at Baycrest
ClinicalTrials.gov Identifier:
NCT00594737
First received: January 7, 2008
Last updated: June 1, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Metabolic activity in frontal and temporal lobes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Drug: memantine hydrochloride
    memantine hydrochloride oral tablets, 10mg po bid
    Other Names:
    • Ebixa
    • Namenda
  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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594737

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

Additional Information:
Publications:
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, Fam D, Graff-Guerrero A, Binns MA, Verhoeff NPG, Tang-Wai D, 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. International Journal of Geriatric Psychiatry 2012 [in press].

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
Pick Disease of the Brain
Aphasia, Primary Progressive
Dementia
Aphasia
Brain Diseases
Central Nervous System Diseases
Communication Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Frontotemporal Lobar Degeneration
Language Disorders
Mental Disorders
Metabolic Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurodegenerative Diseases
Neurologic Manifestations
Proteostasis Deficiencies
Signs and Symptoms
Speech Disorders
TDP-43 Proteinopathies
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 27, 2014