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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group OD (Orodispersible Memantine) | Active Comparator | Sinolvir® (Orodispersible Memantine) 10 mg. |
|
| Group MTb (conventional Memantine Tablets) | Active Comparator | Eutebrol® (conventional Memantine Tablets) 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | orodispersible memantine administered according to a dose titration schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver treatment satisfaction assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) | 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. | Between Day 71 and Day 80 after treatment initiation. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Mimenza Alvarado, Dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Saltillo | Coahuila | 44670 | Mexico | ||
| Private Geriatrics Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24329892 | Background | Affoo RH, Foley N, Rosenbek J, Kevin Shoemaker J, Martin RE. Swallowing dysfunction and autonomic nervous system dysfunction in Alzheimer's disease: a scoping review of the evidence. J Am Geriatr Soc. 2013 Dec;61(12):2203-2213. doi: 10.1111/jgs.12553. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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This was a Phase IV, randomized, open-label, parallel-design clinical study in which patients were assigned in a 1:1 ratio to receive orodispersible memantine (OD)(Sinolvir®) or conventional memantine tablets (MTb)(Eutebrol®), with the aim of evaluating satisfaction with the use of both formulations.
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| Memantine Oral Tablet | Drug | Conventional memantine tablets administered according to a dose titration schedule. |
|
| Guadalajara |
| Jalisco |
| 44670 |
| Mexico |
| Private Practice | Monterrey | Nuevo León | 64520 | Mexico |
| Hospital Ángeles del Pedregal | Mexico City | 10700 | Mexico |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |