Memantine in patients with frontotemporal lobar degeneration: a multicentre, randomised, double-blind, placebo-controlled trial
Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective trea...
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| Published in | Lancet neurology Vol. 12; no. 2; pp. 149 - 156 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
01.02.2013
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1474-4422 1474-4465 1474-4465 |
| DOI | 10.1016/S1474-4422(12)70320-4 |
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| Abstract | Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD.
We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974.
Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients’ preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI −3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, −0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one).
Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD.
Forest Research Institute. |
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| AbstractList | Summary Background Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD. Methods We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov , number NCT00545974. Findings Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients’ preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI −3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, −0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one). Interpretation Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD. Funding Forest Research Institute. Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD. We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974. Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients’ preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI −3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, −0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one). Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD. Forest Research Institute. Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD.BACKGROUNDMemantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD.We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974.METHODSWe did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974.Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients' preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI -3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, -0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one).FINDINGSOf 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients' preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI -3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, -0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one).Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD.INTERPRETATIONMemantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD.Forest Research Institute.FUNDINGForest Research Institute. Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD. Methods: We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1: 1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974. Findings: Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patientsa preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2ADT2, 95% CI -3ADT9 to 8ADT3, p=0ADT47) or CGIC (mean difference 0ADT0, -0ADT4 to 0ADT4, p=0ADT90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one). Interpretation: Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD. Funding: Forest Research Institute. Background Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD. Methods We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered withClinicaltrials.gov, numberNCT00545974. Findings Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients' preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI -3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, -0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one). Interpretation Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD. Funding Forest Research Institute. Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD. We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00545974. Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients' preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI -3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, -0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one). Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD. Forest Research Institute. |
| Author | Fields, Scott Lerner, Alan Sullivan, Kathryn Ullah, Jerin Mesulam, M Marsel Neuhaus, John Kramer, Joel H Graf-Radford, Neill Boxer, Adam L Onyike, Chiadi Lipowski, Kristine Kaufer, Daniel I Kerwin, Diana Grossman, Murray Mendez, Mario Wu, Chuang-Kuo Merrilees, Jennifer Shapira, Jill Klepac, Kristen Koestler, Mary Knopman, David S Miller, Bruce L |
| Author_xml | – sequence: 1 givenname: Adam L surname: Boxer fullname: Boxer, Adam L email: aboxer@memory.ucsf.edu organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 2 givenname: David S surname: Knopman fullname: Knopman, David S organization: Department of Neurology, Mayo Clinic, Rochester, MN, USA – sequence: 3 givenname: Daniel I surname: Kaufer fullname: Kaufer, Daniel I organization: Department of Neurology, University of North Carolina, Chapel Hill, NC, USA – sequence: 4 givenname: Murray surname: Grossman fullname: Grossman, Murray organization: Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA – sequence: 5 givenname: Chiadi surname: Onyike fullname: Onyike, Chiadi organization: Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA – sequence: 6 givenname: Neill surname: Graf-Radford fullname: Graf-Radford, Neill organization: Department of Neurology, Mayo Clinic, Jacksonville, FL, USA – sequence: 7 givenname: Mario surname: Mendez fullname: Mendez, Mario organization: Department of Neurology, University of California, Los Angeles, CA, USA – sequence: 8 givenname: Diana surname: Kerwin fullname: Kerwin, Diana organization: Cognitive Neurology and Alzheimer Disease Center of Northwestern University, Chicago, IL, USA – sequence: 9 givenname: Alan surname: Lerner fullname: Lerner, Alan organization: Department of Neurology, Case-Western University, Cleveland, OH, USA – sequence: 10 givenname: Chuang-Kuo surname: Wu fullname: Wu, Chuang-Kuo organization: Department of Neurology, Texas Tech University, Lubbock, TX, USA – sequence: 11 givenname: Mary surname: Koestler fullname: Koestler, Mary organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 12 givenname: Jill surname: Shapira fullname: Shapira, Jill organization: Department of Neurology, University of California, Los Angeles, CA, USA – sequence: 13 givenname: Kathryn surname: Sullivan fullname: Sullivan, Kathryn organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 14 givenname: Kristen surname: Klepac fullname: Klepac, Kristen organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 15 givenname: Kristine surname: Lipowski fullname: Lipowski, Kristine organization: Cognitive Neurology and Alzheimer Disease Center of Northwestern University, Chicago, IL, USA – sequence: 16 givenname: Jerin surname: Ullah fullname: Ullah, Jerin organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 17 givenname: Scott surname: Fields fullname: Fields, Scott organization: Department of Clinical Pharmacy, University of California, San Francisco, CA, USA – sequence: 18 givenname: Joel H surname: Kramer fullname: Kramer, Joel H organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 19 givenname: Jennifer surname: Merrilees fullname: Merrilees, Jennifer organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA – sequence: 20 givenname: John surname: Neuhaus fullname: Neuhaus, John organization: Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA – sequence: 21 givenname: M Marsel surname: Mesulam fullname: Mesulam, M Marsel organization: Cognitive Neurology and Alzheimer Disease Center of Northwestern University, Chicago, IL, USA – sequence: 22 givenname: Bruce L surname: Miller fullname: Miller, Bruce L organization: Memory and Aging Center, Department of Neurology, University of California, San Francisco, CA, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23290598$$D View this record in MEDLINE/PubMed |
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| Snippet | Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit... Summary Background Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a... Background Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient,... |
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| SubjectTerms | Acetylcholinesterase Aged Alzheimer's disease Antipsychotics Aphasia Atrophy Behavior Blister packs Brain Caregivers Chi-Square Distribution Cholinesterase Clinical trials Cognitive ability Data processing Dementia Disease Double-Blind Method Drug dosages Excitatory Amino Acid Antagonists - therapeutic use FDA approval Female Follow-Up Studies Forests Frontotemporal dementia Frontotemporal Lobar Degeneration - drug therapy Humans Inventories Male memantine Memantine - therapeutic use Middle Aged Motivation Neurology Neuropsychological Tests Neuropsychology Parkinson's disease Patients Personnel Psychiatric Status Rating Scales Psychotropic drugs Retrospective Studies semantic dementia Semantics Tablets Treatment Outcome |
| Title | Memantine in patients with frontotemporal lobar degeneration: a multicentre, randomised, double-blind, placebo-controlled trial |
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