Alzheimer DiseasePhase 4NCT07417670
Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease
A Phase 4 study testing Memantine and Memantine Oral Tablet in people with Alzheimer Disease, run by Carnot Laboratories at 4 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Memantine and Memantine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesMexico
- Study dates
- 4 Oct 2024to 18 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 were excluded, based on any of the following scales:
- Mini-Mental State Examination (MMSE) score > 18; or Montreal Cognitive Assessment (MoCA) score > 18.
- Patients with uncontrolled depression (including major depressive disorder) within the last three months were excluded, according to:
- Geriatric Depression Scale (GDS) (Yesavage), short form, score ≥ 10.
- Patients with uncontrolled anxiety within the last three months were excluded, according to:
Show all 13Show fewer
- Hamilton Anxiety Rating Scale (HAM-A) score ≥ 8.
- Patients with contraindications or any other condition preventing the use of memantine, in accordance with the approved prescribing information for SINOLVIR® or EUTEBROL®, were excluded.
- Primary caregivers who refused to participate or who were unable to complete the study due to severe sensory impairment or for any other reason were excluded.
- Patients with psychiatric disorders or symptoms of non-Alzheimer's disease origin that were active or decompensated at study entry (e.g., delirium, schizophrenia) were excluded.
- Patients with active alcohol use at study entry were excluded.
- Patients with unstable or uncontrolled neurological conditions, such as active autoimmune or infectious encephalitis, uncontrolled epilepsy, uncontrolled multiple sclerosis, or uncontrolled amyotrophic lateral sclerosis, were excluded.
- Patients with active brain neoplasms at study entry were excluded.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Private Geriatrics Practice
Guadalajara, Jalisco, 44670
Hospital Ángeles del Pedregal
Mexico City, 10700
Private Practice
Monterrey, Nuevo León, 64520
Private Practice
Saltillo, Coahuila, 44670
About this study
Official title: 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.
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:
Read more
- 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.
- Conditions
- Alzheimer Disease
- Being tested
- Memantine, Memantine Oral Tablet
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
orodispersible memantine administered according to a dose titration schedule.
Memantine Oral TabletDrug
Conventional memantine tablets administered according to a dose titration schedule.
| Study group | Role | What they receive |
|---|---|---|
| Group OD (Orodispersible Memantine) | Active comparator | Sinolvir® (Orodispersible Memantine) 10 mg. Receives: Drug: Memantine |
| Group MTb (conventional Memantine Tablets) | Active comparator | Eutebrol® (conventional Memantine Tablets) 10 mg. Receives: Drug: Memantine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between Day 71 and Day 80 after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start4 Oct 2024
- Primary completion12 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnot Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Mimenza Alvarado, Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417670
- Sponsor's protocol ID
- PEO-CAR-MEM-01-2023
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24329892
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07417670
- Acronym / sponsor ID
- PEO-CAR-MEM-01-2023
- Conditions
- Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Carnot LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group OD (Orodispersible Memantine) | Active comparator | Drug: MemantineSinolvir® (Orodispersible Memantine) 10 mg. |
| Group MTb (conventional Memantine Tablets) | Active comparator | Drug: Memantine Oral TabletEutebrol® (conventional Memantine Tablets) 10 mg. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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 were excluded, based on any of the following scales:
- Mini-Mental State Examination (MMSE) score > 18; or Montreal Cognitive Assessment (MoCA) score > 18.
- Patients with uncontrolled depression (including major depressive disorder) within the last three months were excluded, according to:
- Geriatric Depression Scale (GDS) (Yesavage), short form, score ≥ 10.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantineorodispersible memantine administered according to a dose titration schedule. | Drug | Group OD (Orodispersible Memantine) |
| Memantine Oral TabletConventional memantine tablets administered according to a dose titration schedule. | Drug | Group MTb (conventional Memantine Tablets) |
Primary outcome
Caregiver treatment satisfaction assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 24329892Affoo 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.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Recruiting
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
Alzheimer Disease
Active, not recruitingPhase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Mimenza Alvarado, Dr. principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine and Memantine Oral Tablet in people with Alzheimer Disease, run by Carnot Laboratories at 4 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver treatment satisfaction assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) (time frame: Between Day 71 and Day 80 after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.