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

Last updated: June 1, 2012
Sponsor: Tiffany Chow, MD
Overall Status: Completed

Phase

3

Condition

Memory Loss

Dementia

Frontotemporal Dementia

Treatment

N/A

Clinical Study ID

NCT00594737
Baycrest.Ebixa.FTD-001
Lundbeck 11627A
  • Ages 40-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 dosingregimen for 3 months prior to trial enrollment

  • On the basis of a physical examination, medical history (including psychiatric andneurological), and results of blood chemistry carried out at screening visit, thepatient in the investigator's opinion is considered healthy.

  • Signed Informed Consent must be obtained from the patient or legally responsiblerepresentative and the informant prior to initiating any study specific procedures.

Exclusion

Exclusion Criteria:

  • Complaint of recurrent or persistent dizziness or constipation

  • Abnormal chemistry panel particular with respect to ruling out renal insufficiency orfailure. 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 hasbeen stable for at least the past year and is judged by the investigators not tointerfere 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 ofFTD (including, but not limited to, stroke, Parkinson's disease, any psychoticdisorder, severe bipolar or unipolar depression) within the past year

  • Current or prior history of uncontrolled seizure disorder, due to seizures reported asadverse events with memantine.

  • Patients with suspected alcohol or substance abuse within last 1 year. If past historyof abuse or dependence must have been abstinent for 1 year with continuing progressionof 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 atthe age of onset of FTD, we do not anticipate having to exclude more than onepotential subject on the basis of this one exclusion criterion.

  • Use of investigational drugs or participation in another investigational drug studywithin 3 months of screening.

  • Patients who have previously been treated with memantine or have participated in aninvestigational study with memantine.

  • Patients with history of severe drug allergy or hypersensitivity or knownhypersensitivity to amantadine or memantine.

Study Design

Total Participants: 17
Study Start date:
October 01, 2007
Estimated Completion Date:
June 30, 2012

Connect with a study center

  • Baycrest

    Toronto, Ontario M6A 2E1
    Canada

    Site Not Available

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