Actively Recruiting
Effects of Rotigotine 4mg/24 Hrs Combined with Rivastigmine 9.5mg/24 Hrs in Mild to Moderate Alzheimer's Disease Patients: A 24-Week Randomized, Double-Blind, Placebo-Controlled Phase III Study
Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2025-01-22
348
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of rotigotine combined with rivastigmine in people with mild to moderate Alzheimer's disease. This phase III, 24-week study compares this combination to rivastigmine with a placebo patch. The study design is randomized and double-blind to reduce bias and improve reliability of results. Participants will receive either a rotigotine 4 mg/24 hours transdermal patch or a placebo patch, alongside rivastigmine, for 24 weeks. The study includes baseline assessments followed by treatment visits at Weeks 6, 12, and 24. EEG exams and plasma biomarker collections happen at the start and end of the study. Caregivers will also be contacted by phone between visits and additional visits may occur if safety concerns arise. During the study, participants will have physical and neurological exams, vital signs measured, and adverse events recorded at screening and each visit. Cognitive and behavioral assessments will measure changes in frontal lobe function, daily living activities, cognition, memory, and apathy. The total participation time is 24 weeks, with close monitoring to ensure safety and collect comprehensive data on treatment effects.
CONDITIONS
Brief Title
A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (non-childbearing potential) diagnosed with Alzheimer's disease according to IWG criteria
- Age between 50 and 85 years
- MRI or CT scan supporting Alzheimer's diagnosis and excluding other dementia causes
- CSF biomarker data or positive Amyloid PET scan confirming Alzheimer's diagnosis (for Czech Republic, lumbar puncture may be performed)
- Stable treatment with rivastigmine patch for at least 3 months, with last month at 9.5 mg/day, or 1 month if switched from donepezil
- Mild to moderate Alzheimer's disease with MMSE score between 18 and 26
- Clinical Dementia Rating (CDR) total score of 0.5 or 1
- Evidence of frontal lobe dysfunction with FAB score ≤14
- No major depression (GDS score less than 5)
- At least five years of formal education
- Documented cognitive decline for more than six months
- Availability of a caregiver living with or interacting regularly with the patient
- Patient living at home or nursing home without continuous nursing care
- General health status suitable for 6-month clinical trial participation
- Stable treatment for other chronic conditions for at least one month
- No regular intake of prohibited medications
- Signed informed consent by patient and caregiver
You will not qualify if you...
- Failure to complete screening or baseline exams
- Hospitalization or change in chronic medications within one month before or during screening
- Diagnosed with other primary degenerative dementias or neurodegenerative diseases
- Presence of orthostatic hypotension or autonomic disorders
- Cerebrovascular disease including major infarcts or extensive white matter lesions
- Other central nervous system diseases such as severe head trauma or tumors
- Seizure disorders
- Infectious, metabolic, or systemic diseases affecting the central nervous system
- Active major depression, schizophrenia, or bipolar disorder
- Any suicidal ideation or behavior
- Advanced or unstable diseases interfering with assessments or posing risk, including psychosis history, liver, respiratory, renal, heart diseases, bradycardia, tachycardia, severe hypertension or hypotension
- Specific heart rhythm disorders or congenital syndromes
- Uncontrolled diabetes (HbA1c >8.5)
- Recent malignancies except certain skin or prostate cancers
- Disabilities preventing study completion (e.g., blindness, deafness)
- Women of childbearing potential
- Chronic daily use or expected use of certain sedatives, antiepileptics, opioids, or nootropic drugs (except Ginkgo Biloba)
- Known or suspected drug or alcohol abuse
- Allergies to study treatment components
- Participation in another investigational study within three months
- Any condition deemed unsuitable by investigator
- Dependence on sponsor or investigator or judicial/administrative confinement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive rotigotine or placebo transdermal patches combined with rivastigmine for 24 weeks. Cognitive and behavioral assessments, EEG exams, and plasma biomarker collections are performed during treatment.
In-clinic visits at Baseline, Weeks 6, 12, and 24, plus telephone contacts at Weeks 4 and 16; unscheduled visits may occur if needed
Trial Site Locations
Total: 1 location
1
Santa Lucia Foundation
Rome, Italy, Italy, 00179
Actively Recruiting
Research Team
G
Giacomo Koch, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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