Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease (NCT07417670) | Clinical Trial Compass
CompletedPhase 4
Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease
Mexico105 participantsStarted 2024-10-04
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of Alzheimer's disease were selected according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
* Patients had moderate to severe Alzheimer's disease, based on the following assessments:
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.
* Patients were considered eligible when memantine was selected as the therapeutic option for Alzheimer's disease, according to the treating physician's clinical judgment.
* Only patients who were prescribed memantine for the first time were included.
* Patients were included if they attended the clinical visit accompanied by their primary caregiver, and if the caregiver agreed to participate and signed the corresponding informed consent.
* The primary caregiver had Spanish as their native language or demonstrated functional proficiency in the language.
Exclusion Criteria:
* Patients with a diagnosis of preclinical Alzheimer's disease were excluded.
* Patients with a diagnosis of Alzheimer's disease at a stage other than moderate to severe …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Caregiver treatment satisfaction assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Timeframe: Between Day 71 and Day 80 after treatment initiation.