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CompletedPhase 4Results posted

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

Asset

Memantine

Listed sites

9

Recruiting sites

-

Enrollment

81

actual

Study population

Frontotemporal dementia

Key I/E criteria

Symptomatic FTDMMSE ≥15Study 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

Org study IDNAM-53:memantineplacebo
NCT IDNCT00545974

Timeline

Milestones

Study start2007-10 (month precision)
Study first posted2007-10-18estimated
Primary completion2012-12actual (month precision)
Study completion2012-12actual (month precision)
Results first posted2014-02-05estimated
Last update posted2020-11-17actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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
Executive function / language
2
Behavior / neuropsychiatric
2
Other clinical outcomes
2
Other (unclassified)
2

Global cognition

2 endpoints
Secondary/protocol endpoint

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

Secondary/registry result

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

GroupValue (mean), units on a scaleReported bounds
MemantineCDR-SBn=37 Participants1.5-0.9 - 2.1
FAQn=37 Participants4.3-2.7 - 6.0
TFLSn=37 Participants-3.7--5.7 - -1.7
MMSEn=37 Participants-1.2--2.5 - 0.1
EXIT25n=37 Participants1.9--0.1 - 3.9
UPDRSn=37 Participants1.7--0.1 - 3.4
Boston naming testn=37 Participants-1.4--2.9 - 0.0
PlaceboCDR-SBn=39 Participants1.5-0.8 - 2.1
FAQn=39 Participants2.9-1.0 - 4.7
TFLSn=39 Participants-2.8--4.4 - -1.1
MMSEn=39 Participants-0.9--1.8 - 0.0
EXIT25n=39 Participants0.7--1.1 - 2.4
UPDRSn=39 Participants1.4--0.7 - 3.4
Boston naming testn=39 Participants0.7-0.3 - 1.2

Executive function / language

2 endpoints
Secondary/protocol endpoint

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

Secondary/registry result

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

GroupValue (mean), number of items recalledReported 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 Participants0.1--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 Participants4.2-1.7 - 10.1
Digits backwardsn=39 Participants-0.2--0.5 - 0.2

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 26 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change in Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 26 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleReported bounds
Memantinen=37 Participants-1.9--6.1 - 2.3
Placebon=39 Participants0.3--4 - 4.7

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Clinical Global Impression of Change (CGIC)

Time frame:26 Weeks

descriptive

Primary/registry result

Clinical Global Impression of Change (CGIC)

Time frame:26 Weeks

descriptive

Posted result

GroupValue (mean), units on a scaleReported bounds
Memantinen=37 Participants4.4-3.7 - 5.2
Placebon=39 Participants4.8-4.8 - 5.1

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Number of Participants Starting Antipsychotic Therapy

Time frame:26 weeks

event count, event

Secondary/registry result/low confidence

Number of Participants Starting Antipsychotic Therapy

Time frame:26 weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Memantinen=37 Participants1-
Placebon=39 Participants2-

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.