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CompletedPhase 4

Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease

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.

Asset

Memantine

Listed sites

4

Recruiting sites

-

Enrollment

105

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤18•MoCA ≤18

Primary endpoint

•Caregiver treatment satisfaction

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07417670
Org study IDPEO-CAR-MEM-01-2023

Timeline

Milestones

Study start2024-10-04actual
Primary completion2025-08-12actual
Study completion2025-08-18actual
Study first posted2026-02-18actual
Last update posted2026-02-18actual

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

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 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:

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Caregiver / quality of life

1 endpoint
Primary/protocol endpoint

Caregiver treatment satisfaction assessed by the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

Time frame:Between Day 71 and Day 80 after treatment initiation.

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.