Actively Recruiting
Study of Rotigotine 4 mg/24 Hours with Rivastigmine for 24 Weeks in Mild to Moderate Alzheimer's Disease Patients to Evaluate Brain Function and Safety
Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2025-01-22
348
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of combining rotigotine with rivastigmine in patients with mild to moderate Alzheimer's disease. It is a phase III, 24-week, prospective, randomized, double-blind, placebo-controlled, multi-center study designed to reduce biases and accurately assess treatment effects in this population aged 50 to 85 years. The study focuses on improving cognitive functions related to the frontal lobe. Participants will receive either a rotigotine 4 mg/24 hours patch or a placebo patch, both combined with rivastigmine 9.5 mg/24 hours, over the 24-week treatment period. Cognitive and behavioral evaluations will be conducted at baseline and at weeks 6, 12, and 24. Additional assessments include EEG neurophysiological exams and plasma biomarker collection at baseline and week 24. Caregivers will have scheduled telephone contacts during weeks 4 and 16, with unscheduled visits arranged if safety concerns arise. Throughout the study, participants will undergo vital sign checks, physical and neurological exams, and adverse event recording at screening, baseline, and scheduled visits. Cognitive changes will be measured by the Frontal Assessment Battery from baseline to week 24. The total participation duration is 24 weeks, and the study includes careful monitoring to evaluate treatment effects and safety.
CONDITIONS
Official 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 aged 50 to 85 years with a diagnosis of Alzheimer's disease according to IWG criteria
- 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 only)
- Stable rivastigmine patch treatment at 9.5 mg/day for at least 3 months or at least one month if switched from donepezil
- Mild to moderate Alzheimer's disease with MMSE score between 18 and 26
- Clinical Dementia Rating total score of 0.5 or 1
- Frontal Assessment Battery score of 14 or less indicating frontal lobe dysfunction
- No major depression (Geriatric Depression Scale score less than 5)
- At least five years of formal education
- Documented cognitive decline for more than six months
- Caregiver available who lives with or regularly interacts with the patient to assist with medication
- Living at home or in a nursing home without continuous nursing care
- General health suitable for a 6-month clinical trial
- Stable treatment for other chronic conditions for at least one month before screening
- No use of prohibited medications
- Signed informed consent by patient and caregiver, with mental capacity verified if needed
You will not qualify if you...
- Failure to complete screening or baseline exams
- Hospitalization or changes in chronic medication within one month before or during screening
- Clinical, lab, or imaging evidence of other dementias or neurological diseases such as Lewy body dementia, frontotemporal dementia, Parkinson's, or cerebrovascular disease
- Active major depression, schizophrenia, or bipolar disorder diagnosis
- Any suicidal thoughts or behavior
- Advanced or unstable diseases that could affect assessments or patient safety, including psychosis, liver, respiratory, kidney, or heart disease
- Heart rate below 50 or above 95 beats per minute
- Blood pressure requiring treatment with more than three drugs
- Certain heart conduction abnormalities or prolonged QT interval
- Uncontrolled diabetes (HbA1c over 8.5)
- Recent malignancies except certain skin cancers or indolent prostate cancer
- Disabilities preventing completion of study requirements
- Women who are fertile and of childbearing potential
- Regular or expected use of certain medications including benzodiazepines, antiepileptics, opioid analgesics, or nootropic drugs (except Ginkgo Biloba)
- Known or suspected drug or alcohol abuse
- Allergy or sensitivity to rotigotine or patch components
- Participation in other investigational studies within three months
- Any condition making the patient unsuitable in the investigator's opinion
- Dependence on the sponsor or investigator or legal/judicial accommodation
AI-Screening
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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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