Trial · NCT02304302
Down Syndrome Memantine Follow-up Study
NCT02304302, Phase 2, Completed, University Hospitals Cleveland Medical Center; results first posted 2022-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Down Syndrome Memantine Follow-up Study. Trials, record NCT02304302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02304302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Down Syndrome Memantine Follow-up Study
- NCT number
- NCT02304302
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Conditions
- Down Syndrome, Intellectual Disability
- Interventions
- Memantine, Placebo
- First posted
- 2014-12-01
- Last updated
- 2023-06-27
- Results first posted
- 2022-04-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | baseline and 16 weeks from start of treatment | 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. |
| Secondary | 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) | baseline and 16 weeks from start of treatment | 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. |
| Secondary | Efficacy of the Drug Memantine as Assessed by Change in Score on the Recall of Digits Forward (From the Differential Ability Scales; DAS-II) | baseline and 16 weeks from start of treatment | 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. |
| Secondary | 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) | baseline and 16 weeks from start of treatment | 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. |
| Secondary | 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) | baseline and 16 weeks from start of treatment | 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). |
| Secondary | Efficacy of the Drug Memantine as Assessed by Change in Score on the Spatial Span (Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB) | baseline and 16 weeks from start of treatment | 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). |
| Secondary | Efficacy of the Drug Memantine as Assessed by Change in Score on the The Go - No Go Task | baseline and 16 weeks from start of treatment | 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). |
| Secondary | Safety and Tolerability of the Drug Memantine as Assessed by Change in QTc Interval | baseline and 16 weeks from start of treatment | 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. |
| Other | Intellectual Functioning of the Participants as Assessed by Change in Score on the Matrices Subtest of the Differential Ability Scales-II (DAS-II) | baseline and 16 weeks from start of treatment | 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). |
| Other | Linguistic Functioning of the Participants as Assessed by Change in Score on the Test for Reception of Grammar 2nd Edition (TROG-II) | baseline and 16 weeks from start of treatment | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2) | score on a scale | MEAN |
| SECONDARY | 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) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2) | score on a scale | MEAN |
| SECONDARY | Efficacy of the Drug Memantine as Assessed by Change in Score on the Recall of Digits Forward (From the Differential Ability Scales; DAS-II) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
| SECONDARY | 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) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
| SECONDARY | 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) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
| SECONDARY | Efficacy of the Drug Memantine as Assessed by Change in Score on the Spatial Span (Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
| SECONDARY | Efficacy of the Drug Memantine as Assessed by Change in Score on the The Go - No Go Task | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). Notice that, for this specific test, some participants stopped midway. | ms | MEAN |
| SECONDARY | Safety and Tolerability of the Drug Memantine as Assessed by Change in QTc Interval | baseline and 16 weeks from start of treatment | The analysis population consisted of all participants who started treatment and had good-quality ECGs before and after the start of memantine treatment, whether or not they completed the entire treatment. | ms | MEAN |
| OTHER_PRE_SPECIFIED | Intellectual Functioning of the Participants as Assessed by Change in Score on the Matrices Subtest of the Differential Ability Scales-II (DAS-II) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Linguistic Functioning of the Participants as Assessed by Change in Score on the Test for Reception of Grammar 2nd Edition (TROG-II) | baseline and 16 weeks from start of treatment | The analysis population consisted of participants who completed 16 weeks of treatment and had neuropsychological assessments at baseline (T1) and after treatment (T2). | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo | 3.3 | Standard Deviation 5.15 | score on a scale | |
| 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 | Memantine | 3.49 | Standard Deviation 4.5 | score on a scale | |
| 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) | Placebo | 1 | Standard Deviation 3.76 | score on a scale | |
| 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) | Memantine | 0.67 | Standard Deviation 3.83 | score on a scale | |
| Efficacy of the Drug Memantine as Assessed by Change in Score on the Recall of Digits Forward (From the Differential Ability Scales; DAS-II) | Placebo | 0.03 | Standard Deviation 2.37 | score on a scale | |
| Efficacy of the Drug Memantine as Assessed by Change in Score on the Recall of Digits Forward (From the Differential Ability Scales; DAS-II) | Memantine | -0.01 | Standard Deviation 1.93 | score on a scale | |
| 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) | Placebo | 0.45 | Standard Deviation 4.24 | score on a scale | |
| 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) | Memantine | -0.05 | Standard Deviation 4.48 | score on a scale | |
| 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) | Placebo | -0.09 | Standard Deviation 11.99 | score on a scale | |
| 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) | Memantine | -1.4 | Standard Deviation 11.66 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 79 | |
| Overall Study | STARTED | Memantine | 81 | |
| Overall Study | COMPLETED | Placebo | 76 | |
| Overall Study | COMPLETED | Memantine | 73 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Memantine | 8 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Signs and symptoms of upper respiratory viral infection | Infections and infestations | Placebo | 12 | 79 | |
| other | Signs and symptoms of upper respiratory viral infection | Infections and infestations | Memantine | 9 | 81 | |
| other | Transient dizziness | General disorders | Placebo | 6 | 79 | |
| other | Transient dizziness | General disorders | Memantine | 8 | 81 | |
| other | Anxiety | Psychiatric disorders | Placebo | 4 | 79 | |
| other | Anxiety | Psychiatric disorders | Memantine | 6 | 81 | |
| other | Mood changes or irritability | Psychiatric disorders | Placebo | 5 | 79 | |
| other | Mood changes or irritability | Psychiatric disorders | Memantine | 2 | 81 | |
| other | Mood changes or sadness | Psychiatric disorders | Placebo | 3 | 79 | |
| other | Mood changes or sadness | Psychiatric disorders | Memantine | 3 | 81 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 79 |
| Total, all-cause mortality | Memantine | 0 | 81 |
| Total, other adverse events | Placebo | 44 | 79 |
| Total, other adverse events | Memantine | 32 | 81 |
| Total, serious adverse events | Placebo | 0 | 79 |
| Total, serious adverse events | Memantine | 0 | 81 |
Source ClinicalTrials.gov
Papers59
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Memantine vs Placebo: deaths from any cause | Trial comparisons |
| Memantine vs Placebo: serious adverse events | Trial comparisons |
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Paired Associate Learning | Secondary outcome | ConductCognition |
| Pattern Recognition Memory | Secondary outcome | ConductCognition |
| Vocabulary Test | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02304302
GET https://conductscience.org/api/trials/v1/NCT02304302/results?page=2