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Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00594737•Tiffany Chow, MD

View on ClinicalTrials.gov

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

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (1)

Baycrest

Toronto, Ontario, Canada

Key Dates

Start Date

October 1, 2007

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

June 4, 2012

Enrollment

ACTUAL participants

Conditions

Frontotemporal Dementia

Interventions

memantine hydrochloride

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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