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Memantine in behavioral variant frontotemporal dementia: negative results
Martine Vercelletto1, Claire Boutoleau-Bretonnière, Christelle Volteau
1CMRR, Centre d'Investigation Clinique, Clinique Neurologique, Hôpital R et G Laënnec, Boulevard Jacques Monod, Nantes, France. martine.vercelletto@chu-nantes.fr
Abstract:
We tested the efficacy and tolerability of one-year treatment with memantine (10 mg bid) in behavioral variant frontotemporal dementia (bvFTD). BvFTD patients aged 45 to 75 years, with a Mini-Mental Status Examination (MMSE) score ≥19, were enrolled in a national, randomized, double-blind, placebo-controlled (DBPC), Phase II trial. The primary endpoint was the CIBIC-Plus (Clinician's Interview-Based Impression of Change Plus Caregiver Input). The secondary endpoints included: Neuropsychiatric Inventory (NPI), Frontal Behavioral Inventory (FBI), Mattis Dementia Rating Scale (MDRS), MMSE, Disability Assessment for Dementia (DAD), and the Zarit Burden Inventory (ZBI). Forty-nine patients were analyzed. At baseline, mean age was 65.6 years and mean MMSE was 25.0 (range: 19-30). On the CIBIC-Plus, 52 weeks after baseline, there were no significant differences between the memantine group (n = 23) and the placebo group (n = 26); p = 0.4458; however, 10 patients had worsened in the memantine group versus 17 in the placebo group. For the secondary endpoints there were no differences in the evolution of score between the memantine group and the placebo group (MMSE, p = 0.63); (MDRS, p = 0.95); (NPI, p = 0.25); (ZBI, p = 0.43); (DAD, p = 0.10) except for the FBI score, which was lower in the memantine group (p = 0.0417). Memantine was well-tolerated. This is the first DBPC trial in a large group of bvFTD patients involving neuroprotective treatment. A multinational study with a larger number of patients is now needed in order to verify the results of our study. The trial is registered with ClinicalTrials.gov; number NCT 00200538.
Insights
Memantine did not significantly improve behavioral variant frontotemporal dementia (bvFTD) symptoms in a one-year trial. While generally well-tolerated, memantine showed no overall benefit over placebo, though it lowered behavioral scores on one measure.
Area of Science:
- Neuroscience
- Clinical Neurology
- Pharmacology
Background:
- Behavioral variant frontotemporal dementia (bvFTD) is a neurodegenerative disorder characterized by profound changes in personality and behavior.
- Current treatment options for bvFTD are limited, highlighting the need for effective therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and tolerability of memantine as a neuroprotective treatment for patients with behavioral variant frontotemporal dementia (bvFTD).
Main Methods:
- A national, randomized, double-blind, placebo-controlled (DBPC) Phase II trial was conducted.
- Participants (n=49) aged 45-75 with MMSE score ≥19 received memantine (10 mg bid) or placebo for 52 weeks.
- Primary endpoint: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). Secondary endpoints included NPI, FBI, MDRS, MMSE, DAD, and ZBI.
Main Results:
- No significant differences were observed between memantine and placebo groups for the primary endpoint (CIBIC-Plus, p=0.4458).
- Secondary endpoints also showed no significant differences, except for the Frontal Behavioral Inventory (FBI) score, which was lower in the memantine group (p=0.0417).
- Memantine was well-tolerated by patients throughout the study.
Conclusions:
- One-year memantine treatment did not demonstrate significant efficacy in improving overall clinical status or most behavioral symptoms in bvFTD patients compared to placebo.
- The observed reduction in FBI scores suggests a potential, albeit limited, benefit on specific behavioral aspects.
- Further multinational studies with larger cohorts are warranted to confirm these findings and explore memantine's role in bvFTD management.
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