Actively Recruiting
A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
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 is a 24-week prospective, randomized, double-blind, placebo-controlled, multi-center phase III study evaluating efficacy and safety of rotigotine 4mg/24 hrs in combination with rivastigmine 9.5 mg/24 hrs in mild to moderate AD patients. The total study duration per patient from baseline to the end will be 24 weeks. The study has a placebo-controlled design to eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources.
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
AI-Powered 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
CONTACT
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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