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Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Lead sponsor
Asset
Memantine
Listed sites
9
Recruiting sites
-
Enrollment
81
actual
Study population
Frontotemporal dementia
Key I/E criteria
•Symptomatic FTD•MMSE ≥15•Study partner/caregiver required
Primary endpoints
•Neuropsychiatric Inventory (NPI)•Clinical Global Impression of Change (CGIC)
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
A subject must meet ALL of the following criteria to be considered for enrollment in this study:
1. Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations.
2. Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic dementia (SD)
3. Age: 40-80
4. CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.
5. MMSE ≥ 15 at screening visit.
6. Judged by investigator to be able to comply with neuropsychological evaluation at baseline.
7. Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak English fluently in order to ensure comprehension of informed consent form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
8. In the opinion of the investigator, the patient and the caregiver will be compliant with the protocol and have a high probability of completing the study
Exclusion criteria
Any one of the following will exclude a subject from being enrolled into the study:
1. Insufficient fluency in English to complete neuropsychological and functional assessments.
2. Concurrent Motor Neuron Disease judged by investigator to have bulbar or upper extremity impairments at baseline that would interfere with neuropsychological assessment, or that are expected to lead to such impairments within one month.
3. Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent aphasia by Neary criteria.
4. Use of memantine within 4 weeks prior to randomization.
5. 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, seizure disorder, or head injury with loss of consciousness) within the past year.
6. Concurrent treatment with acetylcholinesterase inhibitors, antipsychotic agents, mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem), or use of any of these agents within 4 weeks prior to randomization. Atypical antipsychotic agents may be started after the baseline visit if felt to be medically necessary by the investigator and will be recorded as a secondary outcome measure.
7. History of alcohol or substance abuse within 1 year prior to screening, if deemed clinically significant by investigator.
8. Any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
9. Clinically significant lab abnormalities at screening, including Creatinine ≥ 1.7, B12 below laboratory normal reference range or TSH above site's laboratory normal reference range. Subjects with abnormal B12 or TSH levels at screening may be included per investigator's discretion.
9. CT or MRI evidence of any of the following: hydrocephalus, stroke, space-occupying lesion, cerebral infection or any clinically significant CNS disease other than FTD.
10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
11. Abnormal ECG at screening judged to be clinically significant by the investigator.
12. Use of investigational drugs or participation in investigational drug study within 60 days of screening.
Endpoints (10)
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.
Coverage by outcome category
Global cognition
2 endpointsLongitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test
Time frame:Baseline and 26 Weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
descriptive
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test
Time frame:Baseline and 26 Weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
descriptive
Posted result
| Group | Value (mean), units on a scale | Reported bounds |
|---|---|---|
| MemantineCDR-SBn=37 Participants | 1.5 | -0.9 - 2.1 |
| FAQn=37 Participants | 4.3 | -2.7 - 6.0 |
| TFLSn=37 Participants | -3.7 | --5.7 - -1.7 |
| MMSEn=37 Participants | -1.2 | --2.5 - 0.1 |
| EXIT25n=37 Participants | 1.9 | --0.1 - 3.9 |
| UPDRSn=37 Participants | 1.7 | --0.1 - 3.4 |
| Boston naming testn=37 Participants | -1.4 | --2.9 - 0.0 |
| PlaceboCDR-SBn=39 Participants | 1.5 | -0.8 - 2.1 |
| FAQn=39 Participants | 2.9 | -1.0 - 4.7 |
| TFLSn=39 Participants | -2.8 | --4.4 - -1.1 |
| MMSEn=39 Participants | -0.9 | --1.8 - 0.0 |
| EXIT25n=39 Participants | 0.7 | --1.1 - 2.4 |
| UPDRSn=39 Participants | 1.4 | --0.7 - 3.4 |
| Boston naming testn=39 Participants | 0.7 | -0.3 - 1.2 |
Executive function / language
2 endpointsLongitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards
Time frame:Baseline and 26 Weeks
event count, event
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards
Time frame:Baseline and 26 Weeks
event count, event
Posted result
| Group | Value (mean), number of items recalled | Reported bounds |
|---|---|---|
| MemantineLetter fluencyn=37 Participants | -0.1 | --1.2 - 1.1 |
| Category fluencyn=37 Participants | -0.5 | --1.9 - 0.9 |
| Digit symboln=37 Participants | -3.9 | --7.5 - -0.3 |
| Digits backwardsn=37 Participants | 0.1 | --0.3 - 0.5 |
| PlaceboLetter fluencyn=39 Participants | -0.3 | --1.1 - 0.4 |
| Category fluencyn=39 Participants | -0.7 | --2.7 - 1.3 |
| Digit symboln=39 Participants | 4.2 | -1.7 - 10.1 |
| Digits backwardsn=39 Participants | -0.2 | --0.5 - 0.2 |
Behavior / neuropsychiatric
2 endpointsChange in Neuropsychiatric Inventory (NPI)
Time frame:Baseline, 26 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Change in Neuropsychiatric Inventory (NPI)
Time frame:Baseline, 26 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | Reported bounds |
|---|---|---|
| Memantinen=37 Participants | -1.9 | --6.1 - 2.3 |
| Placebon=39 Participants | 0.3 | --4 - 4.7 |
Other clinical outcomes
2 endpointsClinical Global Impression of Change (CGIC)
Time frame:26 Weeks
descriptive
Clinical Global Impression of Change (CGIC)
Time frame:26 Weeks
descriptive
Posted result
| Group | Value (mean), units on a scale | Reported bounds |
|---|---|---|
| Memantinen=37 Participants | 4.4 | -3.7 - 5.2 |
| Placebon=39 Participants | 4.8 | -4.8 - 5.1 |
Other (unclassified)
2 endpointsNumber of Participants Starting Antipsychotic Therapy
Time frame:26 weeks
event count, event
Number of Participants Starting Antipsychotic Therapy
Time frame:26 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Memantinen=37 Participants | 1 | - |
| Placebon=39 Participants | 2 | - |
Publications (26)
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
- PMID10885864via BACKGROUND
- PMID9855500via BACKGROUND
- PMID16401843via BACKGROUND
- PMID15554751via BACKGROUND
- PMID1447438via BACKGROUND
- PMID1202204via BACKGROUND
- PMID16477009via BACKGROUND
- PMID12105362via BACKGROUND
- PMID9043744via BACKGROUND
- PMID12672860via BACKGROUND
- PMID8232972via BACKGROUND
- PMID9153155via BACKGROUND
- PMID11417663via BACKGROUND
- PMID16613895via BACKGROUND
- PMID6496779via BACKGROUND
- PMID16401839via BACKGROUND
- PMID14734594via BACKGROUND
- PMID17194818via BACKGROUND
- PMID16424917via BACKGROUND
- PMID7905600via BACKGROUND
- PMID16317256via BACKGROUND
- PMID16718704via BACKGROUND
- PMID12409683via BACKGROUND
- PMID23290598via RESULT
- PMID12497558via BACKGROUND
- PMID16033782via BACKGROUND
Provenance
Sources
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.