Memantine
Drugorodispersible memantine administered according to a dose titration schedule.
NCT Number: NCT07417670
The goal of this clinical study is to evaluate satisfaction with the use of orodispersible Memantine (OD) versus conventional Memantine tablets (MTb) using the validate SATMED-Q in patients with moderate to severe Alzheimer's disease. Due to the neurocognitive impairment associated with these stages of the disease, treatment satisfaction will be assessed indirectly through the primary caregiver.
The main questions this study seeks to answer are:
* Is caregiver satisfaction higher with OD (Sinolvir®) compared with MTb? * What adverse events or side effects occur in patients receiving memantine in either pharmaceutical form?
Researchers will compare OD (Sinolvir®) and MTb to identify differences in caregiver satisfaction and to describe the adverse events reported. Satisfaction will be evaluated across the six domains of the SATMED-Q questionnaire, and results will be summarized by domain and by pharmaceutical dosage form.
All adverse events reported during the study will be documented.
Participants will receive Sinolvir®(OD) or Eutebrol® (MTb) daily, according to dosing regimens determined by the treating physicians based on the approved prescribing information. The duration of participation will be two months.
After two months of treatment, eligible primary caregivers will complete the SATMED-Q questionnaire. Caregivers will be invited to participate at Visit 1 and will complete the satisfaction questionnaire at Visit 2, which will be conducted between days 60 and 70 after Visit 1.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
Private Practice, Saltillo, Coahuila, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Mini-Mental State Examination (MMSE) score ≤ 18 in patients with more than 12 years of education; or Montreal Cognitive Assessment (MoCA) score ≤ 18 in patients with more than 12 years of education.
Katz Index of Activities of Daily Living score ≤ 6 and Lawton Instrumental Activities of Daily Living scale score < 6 out of 8.
Clinical Dementia Rating (CDR) scale score of 2 or 3.
Exclusion criteria
Mini-Mental State Examination (MMSE) score > 18; or Montreal Cognitive Assessment (MoCA) score > 18.
Geriatric Depression Scale (GDS) (Yesavage), short form, score ≥ 10.
Hamilton Anxiety Rating Scale (HAM-A) score ≥ 8.
orodispersible memantine administered according to a dose titration schedule.
Conventional memantine tablets administered according to a dose titration schedule.
Time frame: Between Day 71 and Day 80 after treatment initiation.
Treatment satisfaction will be assessed using the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q).
The SATMED-Q consists of 17 items grouped into six predefined domains evaluating different aspects of treatment satisfaction, including medication undesirable effects, effectiveness, convenience, impact on daily life, medical follow-up, and overall opinion. Responses to all 17 items will be collected and summarized by domain according to the orodispersible memantine (OD) (Sinolvir®) or conventional Memantine tablets (MTb).
The questionnaire will be administered by the treating physician to the patient's primary caregiver and will represent the sole assessment performed in this study. It will be completed within 10 days after completion of treatment with the study medication, specifically between Day 71 and Day 80 following treatment initiation.
Carnot Laboratories
Industry
COMPARATIVE STUDY TO EVALUATE SATISFACTION WITH THE USE OF ORODISPERSIBLE MEMANTINE TABLETS VERSUS CONVENTIONAL TABLETS IN PATIENTS WITH MODERATE TO SEVERE ALZHEIMER'S DISEASE: A PHASE IV, RANDOMIZED, OPEN-LABEL STUDY.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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