None listed
Conditions
Interventions
Exelon patches of 10 cm2 Type of group
Exelon patch of 10 cm2 will be placed.
Group name:placebo Type of group
Placebos will be administered in patches and capsules similar to the study object.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Los pacientes que cumplieron con los criterios de inclusion y exclusion que figuran en el estudio CENA713D2320 y completaron la fase de tratamiento doble ciego en la medicacion del estudio sin violaciones significativas del protocolo. Ambos sexos, mayores de 50 años.
Exclusion criteria
Exclusion criteria: 1. advanced, severe, progressive, or unstable disease of any kind that may interfere with efficacy and safety assessments or pose a special risk to the patient. 2. any medical or neurological condition, outside the AD, that may explain the dementia of the patient. 3. current diagnosis of probable or possible vascular dementia, according to the criteria of the National Institute of Neurological Disorders and Brain Vascular Injuries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Throughout the treatment of the study, the occurrence of adverse clinical reactions in patients will be monitored. Blood and urine laboratory tests will be performed before randomization. Tolerability assessments will be conducted to accurately assess the potential irritation caused by the patch. Likewise, evaluations of the adherence of the patch will be carried out. Measure:Safety and tolerability measured by adverse events, vital signs and skin irritation for up to 28 weeks of treatment. Timepoints:30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Secondary measures of effectiveness are the Neuropsychiatric Inventory (NPI), including the NPI - Caregiver Scale of Care (NPI-D), the Mini Mental State Examination (MMSE), the Cooperative Study of Alzheimer Disease - Activities. daily life (ADCS-ADL), the Ten-Point Clock Test, the Trail Making Test Part A (TMT), and the Alzheimer Disease Patient Carers Preference Questionnaire (ADCPQ). Measure:Change in cognition from baseline (week 24 of the double blind phase) at week 52 Clinical global impression of change from baseline at week 52 Change in activities of daily living from baseline at week 52 Change in behavioral symptoms from baseline at week 52 Change in executive function from baseline at week 52 Timepoints:30 days | — |
Countries
Argentina, Chile, Czech Republic, Denmark, Finland, Guatemala, Israel, Italy, Korea North, Mexico, Norway, Peru, Poland, Portugal, Russian Federation, Slovakia, Sweden, Taiwan, United States, Uruguay, Venezuela
Outcome results
None listed