Evidence map›Paper›PMID 24345444›Full record

Trial reportThe Journal of clinical psychiatry2014

Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial.

Andreea L Seritan, Danh V Nguyen, Yi Mu, Flora Tassone, James A Bourgeois, Andrea Schneider, Jennifer B Cogswell, Kylee R Cook, Maureen A Leehey, Jim Grigsby and 6 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00584948 (Characterization and Treatment of CNS Abnormalities in Premutation Carriers), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00584948 nacompletednot on this map

Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

TypeinterventionalSponsorUniversity of California, DavisRan2007 to 2012Enrolled94ConditionsFragile X-Associated Tremor/Ataxia Syndrome, Fragile X Premutation CarriersArmsMemantine, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 48 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Open-Label Allopregnanolone Treatment of Men with Fragile X-Associated Tremor/Ataxia Syndrome.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
    Trial
  4. Trial
  5. Memantine effects on verbal memory in fragile X-associated tremor/ataxia syndrome (FXTAS): a double-blind brain potential study.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2014
    Trial
  6. Review
  7. Review
  8. Review
  9. Mouse models of fragile X-related disorders.Disease models & mechanisms · 2023
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Placebo Response in Fragile X-associated Tremor/Ataxia Syndrome.Movement disorders clinical practice · 2020
    Article
  15. Article
  16. Review
  17. Can a Neurosteroid Ameliorate Fragile X-Associated Tremor/Ataxia Syndrome?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
    Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

Andreea L Seritan2230 Stockton Blvd, Sacramento, CA 95817 andreea.seritan@ucdmc.ucdavis.edu.
Danh V Nguyen
Yi Mu
Flora Tassone
James A Bourgeois
Andrea Schneider
Jennifer B Cogswell
Kylee R Cook
Maureen A Leehey
Jim Grigsby
John M Olichney
Patrick E Adams
Wendi Legg
Lin Zhang
Paul J Hagerman
Randi J Hagerman
Institute of Molecular Medicine · IN

Funding

Restoring FMRP Phenotypes Frpm Temporal Regional and Splice- Isoforms VarationsP30HD002274 · NICHD · UNIVERSITY OF WASHINGTON · PI GURALNICK, MICHAEL J · 1985 to 2013
$33.6M
UC DAVIS CLINICAL AND TRANSLATIONAL SCIENCE CENTER: BPCAUL1RR024146 · NCRR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2006 to 2011
$27.0M
GENOTYPE/PHENOTYPE RELATIONSHIPS IN FRAGILE X FAMILIESR01HD036071 · NICHD · UNIVERSITY OF CALIFORNIA DAVIS · PI PAUL J HAGERMAN, RANDI J. HAGERMAN · 1998 to 2026
$13.8M
UC Davis Clinical and Translational Science CenterUL1TR000002 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$12.2M
Institute for Clinical and Translational ScienceUL1TR000153 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M · 2012 to 2015
$12.1M
Characterization and Treatment of CNS Abnormalities in Premutation Carriers (4 ofRL1AG032115 · NIA · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HAGERMAN, RANDI J. · 2007 to 2011
$5.8M
Development of targeted therapeutic agents for the treatment of FXTAS (2 of 6)RL1AG032119 · NIA · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HAGERMAN, PAUL J · 2007 to 2011
$4.1M
Neuro Therapeutics Research Institute (1 of 6)UL1DE019583 · NIDCR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HAGERMAN, PAUL J · 2008 to 2011
$3.0M
NCATS NIH HHS TR00002NCATS NIH HHS TR000153NCATS NIH HHS UL1 TR000002NCATS NIH HHS UL1 TR000153NCRR NIH HHS RR024146NCRR NIH HHS UL1 RR024146NIA NIH HHS RL1 AG032115NIA NIH HHS RL1 AG032119NICHD NIH HHS HD02274NICHD NIH HHS HD036071NICHD NIH HHS P30 HD002274NICHD NIH HHS R01 HD036071NIDCR NIH HHS DE019583NIDCR NIH HHS UL1 DE019583
6 · The paper itself

Abstract

objectiveMemantine, an uncompetitive N-methyl-d-aspartate receptor antagonist, is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer's disease. Anecdotal reports have suggested that memantine may improve neurologic and cognitive symptoms of individuals with the neurodegenerative disease fragile X-associated tremor/ataxia syndrome (FXTAS); however, its efficacy and safety in this population have not been assessed in a controlled trial.

methodIndividuals with FXTAS aged 34-80 years were enrolled in a randomized, double-blind, placebo-controlled, 1-year trial between September 2007 and August 2012. Inclusion required definite, probable, or possible FXTAS in clinical stages 1-5 according to previously published criteria. Primary outcome measures were the Behavioral Dyscontrol Scale (BDS) score and CATSYS intention tremor severity.

resultsNinety-four participants were randomized from 205 screened; of those, 43 and 45 started treatment with memantine (titrated to 10 mg twice daily) and placebo, respectively. Thirty-four participants receiving memantine and 36 receiving placebo completed the 1-year endpoint assessment (n = 70). Intention-to-treat analysis showed no improvement with respect to intention tremor severity (mean [SD] values with memantine vs placebo: 1.05 [0.73] vs 1.89 [2.19], P = .047) or BDS score (16.12 [5.43] vs 15.72 [3.93], P = .727) at follow-up. Post hoc analyses of participants with early FXTAS (stage ≤ 3), those with late FXTAS (stage > 3), and those in different age groups (≤ 65 years and > 65 years) also indicated no significant improvement. More frequent mild adverse events were observed in the placebo group, while more frequent moderate adverse events occurred in the memantine group (P = .007).

conclusionThis randomized, double-blind, placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures.

trial registrationClinicalTrials.gov identifier: NCT00584948.

Indexed as

AdultAgedAged, 80 and overAntiparkinson AgentsAtaxiaDouble-Blind MethodFemaleFragile X SyndromeHumansMaleMemantineMiddle AgedNeuropsychological TestsPlacebosPsychiatric Status Rating ScalesSeverity of Illness IndexAntiparkinson AgentsMemantinePlacebos

Identifiers

PMID24345444
PMCPMC4296896
OpenAlexW2133912210

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.