Trial · NCT07531940
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability (as measured by incidence of adverse events) | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | Incidence of adverse events (AEs) will be monitored by clinical history, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests during and after exposure to the up to three doses of memantine (20, 40, and potentially 60 mg/day; PO). Investigators will record any AE reported by the participants and caregivers and any clinically significant abnormalities. Memantine is expected to be well tolerated at higher than the typical dose used in the treatment of Alzheimer's disease (20 mg/day) by at least 80% of the study participants (more precisely, \< 6 participants will drop out of the study due to AEs related to the study medication). Participation discontinuation can be initiated by either the PI/co-investigators or participant/caregiver. Safety data will be collected at the 40 mg/day dose in the first 10 study participants, and a third dose (60 mg/day) will be added (in consultation with the FDA) for the next 15 participants only if 40 mg/day proves to be safe. |
| Secondary | 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 | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | This secondary outcome measure is focused on episodic memory. The CVLT-III short form assesses supraspan word learning ability as an index of episodic verbal long-term memory. The hypothesis to be tested is 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 will be recorded as change in score from baseline (i.e., before drug intervention or T1) to after the treatment at each of the two-to-three doses and at washout \[T2, T3, T4, and potentially T5 (if the 60 mg/day receives the go-ahead from the FDA\]. Scale Range: from 0 to 36; higher scores represent better outcomes. Different word lists will be used at each testing session to reduce practice effects. |
| 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) | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | This is a measure of rote short-term verbal memory. The hypothesis to be tested is that treatment with memantine will produce significant improvements in this test. Total number of items correct will be used as the dependent variable. The values for this measure will be recorded as change in score from baseline (i.e., before drug intervention or T1) to after the treatment at each of the two-to-three doses and at washout \[T2, T3, T4, and potentially T5 (if the 60 mg/day receives the go-ahead from the FDA\]. The minimum value for this scale is 0 and the maximum value is 38; higher scores mean a better outcome. |
| Other | Exploratory Assessment of Change in Score on the Paired Associates Learning (PAL) From the Cambridge Neuropsychological Test Automated Battery (CANTAB) | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | 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 will be recorded as change in score from baseline (i.e., before drug intervention or T1) to after the treatment at each of the two-to-three doses and at washout \[T2, T3, T4, and potentially T5 (if the 60 mg/day receives the go-ahead from the FDA\]. The minimum value of the PAL Memory Score Scale is 0 and the maximum value is 21; higher scores mean better outcomes. |
| Other | Exploratory Assessment of Change in Score on the Pattern Recognition Memory (PRM; Part of the Cambridge Neuropsychological Test Automated Battery -- CANTAB) | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | This is a measure of non-verbal memory. Total number correct across the two series of items presented will be used as the dependent variable. The values for this measure have been recorded as change in score from baseline (i.e., before drug intervention or T1) to after the treatment at each of the two-to-three doses and at washout \[T2, T3, T4, and potentially T5 (if the 60 mg/day receives the go-ahead from the FDA\]. The PRM total scale will be used 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. |
| Other | Intellectual Functioning of the Participants as Assessed by Change in Score on the Matrices Subtest of the Differential Ability Scales-II (DAS-II) | 18 weeks for the first 10 participants and 27 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | 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. Because 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. Values for this measure will be recorded as changes in score from baseline (T1) to after treatment with the highest tolerable dose of memantine. |
| Other | Linguistic Functioning of the Participants as Assessed by Change in Score on the Test for Reception of Grammar 2nd Edition (TROG-II) | 18 weeks for the first 10 participants and 27 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | This is a measure of receptive syntax skills. 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. Values for this measure will be recorded as changes in score from baseline (T1) to after treatment with the highest tolerable dose of memantine. The minimum value of the scores is 0 and the maximum value is 40; with higher scores considered to be a better outcome. |
| Other | Linguistic Functioning of the Participants as Assessed by Change in Score on the Peabody Picture Vocabulary Test-IV (PPVT-IV) | 18 weeks for the first 10 participants and 27 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | 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 will be used as the dependent variable, following the administration manual's rules for floors and ceilings. Values for this measure will be recorded as changes in score from baseline (T1) to after treatment with the highest tolerable dose of memantine. The minimum value for this scale is 0 and the maximum value is 192, higher scores mean a better outcome. |
| Other | Adaptive/Behavioral Functioning of the Participants as Assessed by Change in Score on the Vineland Adaptive Behavior Scales, Third Edition (Vineland 3) | 18 weeks for the first 10 participants and 27 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | This is a measure of adaptive functioning that integrates information from 4 different domains (Communication, Daily Living Skills, Socialization, Motor Skills). It is in a questionnaire format, which a caregiver can complete while the participant is being tested. The Interview and Parent/Caregiver Form will be used. This form is normed for 3-21 years old. Standard scores for all indices will be derived from age norms and raw score will used as dependent variables. The Broad Independence Score will be recorded as change in score from baseline (T1) to after treatment with the highest tolerable dose of memantine. |
| Other | Measurement of plasma biomarkers of Alzheimer's disease | 27 weeks for the first 10 participants and 36 weeks for the next 15 participants if the 60 mg/day-dose proves to be safe. | The hypothesis to be tested is that either 40 mg/day or 60 mg/day memantine will produce significant improvements in neuropsychological test scores and, potentially, in plasma biomarkers of Alzheimer's disease (such as Aβ40, Aβ42, p-tau181, pTau217, p-tau231, sTREM2, GFAP, and NfL). Assessments of plasma levels will be made as change in biomarker levels from baseline (i.e., before drug intervention or T1) to after the treatment at each of the two-to-three doses and at washout \[T2, T3, T4, and potentially T5 (if the 60 mg/day receives the go-ahead from the FDA\]. |
| Other | Pharmacokinetics (PK): Maximum Plasma Concentration [Cmax] | 197 hours | After the washout phase, a single oral dose (20 mg) will be used to evaluate the absorption, distribution, and excretion of memantine in young individuals with DS, which are expected to approximate first order kinetics. Discomfort caused by blood sampling for PK studies will be minimized by using minimally invasive procedures (finger pricks on a different finger at each prick) to obtain very small blood samples (100-200 microliters). Blood samples will be collected in cryotubes containing the anti-coagulant sodium heparin at pre-dosing, and at 1, 2, 4, 8, 24, 53, 101, and 197 hours after drug administration to perform PK analyses. Gas chromatography/mass spectrometry (GC/MS) will be used to perform measurements of plasma memantine concentrations. The resulting concentration values will be used to construct a concentration-time curve from which Cmax will be derived and expressed in ng/ml. |
| Other | Pharmacokinetics (PK): Time to Reach Cmax (Tmax) | 197 hours | This parameter represents the time taken to reach the peak drug concentration (Cmax) after administration and indicates the rate of drug absorption. Concentration values from the concentration-time curve (see Outcome 11) will be used to calculate Tmax, which will be expressed in hours. |
| Other | Pharmacokinetics (PK): Half-Life (T½) | 197 hours | This parameter represents the time required for the drug concentration in the plasma to decrease by half. T½ will be calculated from the concentration-time curve (see Outcome 11) as the time it will take for the drug concentration to drop from Cmax to one half of Cmax, which will be expressed in hours. |
| Other | Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) | 197 hours | This parameter represents the total drug exposure over time. AUC will be calculated by integrating the concentration-time curve (see Outcome 11) from time 0 to infinity (using a single-exponential decay model) and will be expressed in ng/ml. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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