Page last updated: 2024-10-30

memantine and Fra(X) Syndrome

memantine has been researched along with Fra(X) Syndrome in 9 studies

Research Excerpts

ExcerptRelevanceReference
"Memantine treatment of Fmr1-KO CGCs promoted cell adhesion properties."5.38The therapeutic effect of memantine through the stimulation of synapse formation and dendritic spine maturation in autism and fragile X syndrome. ( Brown, WT; Dobkin, C; Li, X; Malik, M; Sheikh, AM; Wei, H, 2012)
"Memantine was modestly effective in several patients with FXS."5.35Open-label memantine in fragile X syndrome. ( Erickson, CA; McDougle, CJ; Mullett, JE, 2009)
"The fragile X associated tremor/ataxia syndrome (FXTAS) is a neurodegenerative disease associated with the repetition of CGG triplets (55-200 CGG repetitions) in the FMR1 gene."2.61[Fragile X associated tremor/ataxia syndrome: its clinical presentation, pathology, and treatment]. ( Hagerman, RJ; Martinez-Cerdeno, V; Salcedo-Arellano, MJ, 2019)
"Memantine treatment of Fmr1-KO CGCs promoted cell adhesion properties."1.38The therapeutic effect of memantine through the stimulation of synapse formation and dendritic spine maturation in autism and fragile X syndrome. ( Brown, WT; Dobkin, C; Li, X; Malik, M; Sheikh, AM; Wei, H, 2012)
"Memantine was modestly effective in several patients with FXS."1.35Open-label memantine in fragile X syndrome. ( Erickson, CA; McDougle, CJ; Mullett, JE, 2009)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (22.22)29.6817
2010's7 (77.78)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Salcedo-Arellano, MJ1
Hagerman, RJ5
Martinez-Cerdeno, V1
Seritan, AL2
Nguyen, DV2
Mu, Y1
Tassone, F1
Bourgeois, JA2
Schneider, A3
Cogswell, JB2
Cook, KR1
Leehey, MA1
Grigsby, J2
Olichney, JM3
Adams, PE1
Legg, W1
Zhang, L1
Hagerman, PJ2
Yang, JC2
Niu, YQ2
Simon, C2
Chen, L1
Moghaddam, ST1
Rodriguez, A1
Royston, A1
Avar, M1
Brill, R1
Erickson, CA1
Mullett, JE1
McDougle, CJ1
Hall, SS1
Webb, S1
Ortigas, MC1
Olichney, J1
Hall, DA1
Wei, H1
Dobkin, C1
Sheikh, AM1
Malik, M1
Brown, WT1
Li, X1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine[NCT00584948]94 participants (Actual)Interventional2007-09-30Completed
Phase II Multicenter 16-Week Randomized Double Blind Placebo-Controlled Evaluation of the Efficacy, Tolerability and Safety of Memantine Hydrochloride on Enhancing the Cognitive Abilities of Adolescents and Young Adults With Down Syndrome[NCT02304302]Phase 2160 participants (Actual)Interventional2014-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)

The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance. (NCT00584948)
Timeframe: One Year

,
Interventionunits on a scale (Mean)
BaselineOne Year
Memantine17.4415.66
Placebo16.1215.72

Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale

The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2 (NCT00584948)
Timeframe: 1 year

,
Interventionm/s^2 (Mean)
BaselineOne Year
Memantine1.311.77
Placebo1.051.89

Adaptive/Behavioral Functioning of the Participants as Assessed by Change in Score on the Scales of Independent Behavior-Revised (SIB-R)

This is a measure of adaptive functioning that integrates information from 13 different domains (e.g., gross motor, social interaction, eating, toileting, dressing, personal self-care, etc.). It is in a questionnaire format, which a caregiver can complete while the participant is being tested. Standard scores for all indices will be derived from age norms that extend from birth to age 80, as these were used as dependent variables. We report here on the Broad Independence Score recorded as change in score from baseline (T1) to after the treatment (T2). The minimum value of the SIB-R Score Scale in this study was -24 (this number is below 0 because -24 was the minimum value for the worst performing participant in the trial) and the maximum value of this scale is 153; higher scores mean better outcomes. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo6.88
Memantine3.23

Efficacy of the Drug Memantine as Assessed by Change in Score on the California Verbal Learning Test-II (CVLT-II) Short Form Total Free Recall

The primary efficacy measure is focused on episodic memory. The CVLT-II short form assesses supraspan word learning ability as an index of episodic verbal long-term memory. We hypothesize that treatment with memantine will produce significant improvements in this test. The main dependent variable selected, based on prior literature was the total number of target items correct summed across learning trials 1-4. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). Scale Range: from 0 to 36; higher scores represent better outcomes. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo3.3
Memantine3.49

Efficacy of the Drug Memantine as Assessed by Change in Score on the Paired Associates Learning (PAL) From the Cambridge Neuropsychological Test Automated Battery (CANTAB)

This is a measure of non-verbal memory that requires the participant to learn associations between an abstract visual pattern and its location. Two dependent variables have been selected: Total number of items correct on the first trial of each stage, and total number of stages completed. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). The minimum value of the PAL Memory Score Scale is 0 and the maximum value is 21; higher scores mean better outcomes. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo1
Memantine0.67

Efficacy of the Drug Memantine as Assessed by Change in Score on the Pattern Recognition Memory (PRM; Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB)

This is a measure of non-verbal memory. Total number correct across the two series of items presented was used as the dependent variable. We used the PRM total scale in this study, which represents the sum of the PRM correct scores (ranging from 0 to 24) and the PRM delayed scores (ranging from 0 to 24). Therefore, the range of the PRM total scale is from 0 to 48; higher values mean better outcomes. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo0.45
Memantine-0.05

Efficacy of the Drug Memantine as Assessed by Change in Score on the Recall of Digits Forward (From the Differential Ability Scales; DAS-II)

This is a measure of rote short-term verbal memory. Total number of items correct were used as the dependent variable. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). The minimum value for this scale is 0 and the maximum value is 38; higher scores mean a better outcome. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo0.03
Memantine-0.01

Efficacy of the Drug Memantine as Assessed by Change in Score on the Spatial Span (Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB)

This measure is a computerized version of the Corsi Blocks task, a long-standing neuropsychological test. The main dependent variables selected for this test was the span length, which is the longest sequence of numbers recalled accurately. The minimum value of the Spatial Span Length Score Scale is 0 and the maximum value is 9; higher scores mean better outcomes. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo0.13
Memantine0.03

Efficacy of the Drug Memantine as Assessed by Change in Score on the Spatial Working Memory (Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB)

"The test requires participants to search under a series of colored boxes to locate a blue token hidden underneath one of them. During a series of trials, the participant is told that the token will be in a new location each time and that they should not go back to a location he or she has looked in previously. The main dependent variable was the total number of errors (between errors), which indexes the number of times a participant went back to a box where a token had already been found, lower scores mean better performance. The minimum value of the Spatial Working Memory scale is 0 and the maximum value is 137 (which was computed as the equivalent to -4 standard deviations from the mean of this measure); higher scores mean worse outcomes. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2)." (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo-0.09
Memantine-1.4

Efficacy of the Drug Memantine as Assessed by Change in Score on the The Go - No Go Task

"This is a measure of inhibitory control, often used as a marker for prefrontal-striatal function integrity. Specifically, it measures the participant's ability to inhibit pre-potent behavioral responses that have been established by provision of prior go or no-go cues in a classical conditioning paradigm. The main dependent variables selected was speed of response of execution to Go targets. The minimum value of the speed of response of execution to Go targets is 280 milliseconds (ms) and the maximum value is 1000 ms; higher scores mean worse outcomes. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2)." (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionms (Mean)
Placebo-2.52
Memantine0.22

Intellectual Functioning of the Participants as Assessed by Change in Score on the Matrices Subtest of the Differential Ability Scales-II (DAS-II)

This test provides a measure of non-verbal reasoning ability that requires subjects to visually inspect a matrix of 4 or 9 pictures that has a missing piece. Participants have to infer a rule or pattern in the stimuli and select the appropriate response from a range of 4-6 possibilities. Since age norms are not available for individuals older than 17y11m, the ability score will be used as the dependent variable. This is an intermediate score based on Rasch modeling that corrects for different items set being administered to participants. The minimum value of the DAS-II Rasch Score Scale is 0 and the maximum value is 153; higher scores mean better outcomes. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo0.75
Memantine2.66

Linguistic Functioning of the Participants as Assessed by Change in Score on the Peabody Picture Vocabulary Test-IV (PPVT-IV)

This is a measure of receptive semantics, whereby the participant is asked to point to a picture (out of 4) that corresponds to a word spoken by the examiner. As this test has a 0.85 correlation with composite measures of Verbal IQ (i.e. from the Wechsler Intelligence Scale series), it can be used in conjunction with the Matrices subtest to estimate overall intellectual functioning. The total number of items correct was used as the dependent variable, following the administration manual's rules for basals and ceilings. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). The minimum value for this scale is 0 and the maximum value is 192, higher scores mean a better outcome. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo4.46
Memantine5.63

Linguistic Functioning of the Participants as Assessed by Change in Score on the Test for Reception of Grammar 2nd Edition (TROG-II)

This is a measure of receptive syntax skills (Bishop, 1983). Participants are asked to point to a picture (out of 4) that corresponds to a phrase or sentence spoken by the examiner. The total number of items correct (rather than blocks passed) will be used as the dependent variable, following the administration manual's ceiling rule. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). The minimum value of the scores is 0 and the maximum value is 40; with higher scores considered to be a better outcome. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionscore on a scale (Mean)
Placebo0.49
Memantine0.89

Safety and Tolerability of the Drug Memantine as Assessed by Change in QTc Interval

Incidence of adverse events was monitored by clinical history, physical examinations, electrocardiograms (ECGs), clinical laboratory tests, the Screen for Childhood Anxiety Related Emotional Disorders (SCARED). Here, we report the analysis of the effect of memantine treatment on QTc intervals because of its clinical importance for this analysis for potential drug toxicity. QTc intervals ≥ 450 ms are generally considered long, and drug-induced QTc interval prolongations ≥ 60 ms are generally considered clinically relevant. (NCT02304302)
Timeframe: baseline and 16 weeks from start of treatment

Interventionms (Mean)
Placebo-1.30
Memantine-0.11

Reviews

2 reviews available for memantine and Fra(X) Syndrome

ArticleYear
[Fragile X associated tremor/ataxia syndrome: its clinical presentation, pathology, and treatment].
    Revista de neurologia, 2019, Mar-01, Volume: 68, Issue:5

    Topics: Antidepressive Agents; Ataxia; Brain; Deep Brain Stimulation; Female; Fragile X Mental Retardation P

2019
Treatments for fragile X syndrome: a closer look at the data.
    Developmental disabilities research reviews, 2009, Volume: 15, Issue:4

    Topics: Acetylcarnitine; Adrenergic alpha-Agonists; Behavior Therapy; Central Nervous System Stimulants; Clo

2009

Trials

3 trials available for memantine and Fra(X) Syndrome

ArticleYear
Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial.
    The Journal of clinical psychiatry, 2014, Volume: 75, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Antiparkinson Agents; Ataxia; Double-Blind Method; Female; Fragile X

2014
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, Volume: 39, Issue:12

    Topics: Ataxia; Brain; Double-Blind Method; Electroencephalography; Evoked Potentials; Excitatory Amino Acid

2014
Memantine Improves Attentional Processes in Fragile X-Associated Tremor/Ataxia Syndrome: Electrophysiological Evidence from a Randomized Controlled Trial.
    Scientific reports, 2016, Feb-22, Volume: 6

    Topics: Aged; Ataxia; Attention; Cognitive Dysfunction; Drug Administration Schedule; Electroencephalography

2016

Other Studies

4 other studies available for memantine and Fra(X) Syndrome

ArticleYear
Open-label memantine in fragile X syndrome.
    Journal of autism and developmental disorders, 2009, Volume: 39, Issue:12

    Topics: Adolescent; Child; Child Development Disorders, Pervasive; Excitatory Amino Acid Antagonists; Fragil

2009
Drugmakers dance with autism.
    Nature biotechnology, 2010, Volume: 28, Issue:8

    Topics: Adult; Animals; Autistic Disorder; Child; Child, Preschool; Clinical Trials, Phase II as Topic; Clin

2010
Improving fragile X-associated tremor/ataxia syndrome symptoms with memantine and venlafaxine.
    Journal of clinical psychopharmacology, 2010, Volume: 30, Issue:5

    Topics: Aged; Ataxia; Cyclohexanols; Drug Therapy, Combination; Female; Follow-Up Studies; Fragile X Mental

2010
The therapeutic effect of memantine through the stimulation of synapse formation and dendritic spine maturation in autism and fragile X syndrome.
    PloS one, 2012, Volume: 7, Issue:5

    Topics: Animals; Autistic Disorder; Cell Adhesion; Cell Movement; Cells, Cultured; Cerebellum; Dendritic Spi

2012