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CompletedPhase 3

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

Lead sponsor

Tiffany Chow, MD

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age 40-80

Primary endpoint

•Metabolic activity in frontal and temporal lobes

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBaycrest.Ebixa.FTD-001

SecondaryLundbeck 11627A

NCT IDNCT00594737

Timeline

Milestones

Study start2007-10 (month precision)

Study first posted2008-01-16estimated

Primary completion2012-06actual (month precision)

Study completion2012-06actual (month precision)

Last update posted2012-06-04estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Metabolic activity in frontal and temporal lobes.

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

Behavioural inventories, UPDRS Motor scale.

Time frame:6 months

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.