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CompletedNCT00594737Updated Jun 4, 2012

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

A Phase 3 interventional study of memantine hydrochloride in Frontotemporal Dementia, sponsored by Tiffany Chow, MD. Completed at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by Tiffany Chow, MD · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
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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.

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Conditions studied

  • Frontotemporal Dementia

Keywords

  • PET
  • frontotemporal dementia
  • memantine
  • Pick's disease
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In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 17 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

This is the only study on the registry with Tiffany Chow, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Interventions

  • Drugmemantine hydrochloride

    memantine hydrochloride oral tablets, 10mg po bid

    Also known as: Ebixa, Namenda

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What researchers measure

Primary outcomes

  1. Metabolic activity in frontal and temporal lobes.

    Time frame: 6 months

Secondary outcomes

  1. Behavioural inventories, UPDRS Motor scale.

    Time frame: 6 months

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Study locations

1 site
  • Baycrest
    Toronto, Ontario M6A 2E1, Canada
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References and documents

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. PubMed 17545743 ↗
  • 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. PubMed 21792308 ↗
  • 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. PubMed 22674572 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00594737
Lead sponsor
Tiffany Chow, MD
Collaborators
H. Lundbeck A/S
Responsible party
Tiffany Chow, MD (Senior Scientist, Assoc. Prof. University of Toronto, Rotman Research Institute at Baycrest) — Sponsor-investigator
First posted
Jan 16, 2008
Start date
Oct 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jun 4, 2012

Study contacts

Tiffany W Chow, MD
principal investigator · Rotman Research Institute at Baycrest, University of Toronto

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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