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New treatment option for Alzheimer Disease
Official title A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT06702124
What this study is testing
What is Rotigotine 4Mg/24Hrs Patch?
Rotigotine 4Mg/24Hrs Patch is an investigational medicine, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Men and women (non-childbearing potential, as defined in Appendix 2) with a diagnosis of AD according to IWG criteria
- Age 50-85 years
- MRI or computerized tomography (CT) assessment, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia...
You likely can't join if
- , number 3)
- Patients who show CSF biomarker data supporting the diagnosis of AD (for Czech Republic only: lumbar punctures can be performed for screening...
- Stable on a treatment with rivastigmine transdermal patch for at least 3 months, of which at least the last month was at 9.5mg/day, or for one month...
- Mild to moderate stage of AD according to MMSE ≥18 and ≤26
- Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild)
- Evidence of frontal lobe dysfunctions as assessed by FAB ≤14
See the full eligibility criteria
Who can join
- Men and women (non-childbearing potential, as defined in Appendix 2) with a diagnosis of AD according to IWG criteria
- Age 50-85 years
- MRI or computerized tomography (CT) assessment, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions (see
What rules you out
- , number 3)
- Patients who show CSF biomarker data supporting the diagnosis of AD (for Czech Republic only: lumbar punctures can be performed for screening purposes), or patients with a positive Amyloid Pet Scan will qualify for the...
- Stable on a treatment with rivastigmine transdermal patch for at least 3 months, of which at least the last month was at 9.5mg/day, or for one month, if the patient had received donepezil before rivastigmine
- Mild to moderate stage of AD according to MMSE ≥18 and ≤26
- Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild)
- Evidence of frontal lobe dysfunctions as assessed by FAB ≤14
- Absence of major depressive disease according to GDS of \< 5
- Formal education for five or more years
- Previous decline in cognition for more than six months as documented in patient medical records
- A caregiver available and living in the same household or interacting with the patient and available if necessary to assure administration of drug
- Patients living at home or nursing home setting without continuous nursing care
- General health status acceptable for a participation in a 6-month clinical trial
- Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
- No regular intake of prohibited medications
- Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent...
- Failure to perform screening or baseline examinations
- Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period
- Clinical, laboratory or neuro-imaging findings consistent with:
- other primary degenerative dementia (dementia with Lewy bodies, fronto- temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down's syndrome, etc.);
- other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.);
- orthostatic hypotension and autonomic disorders
- cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions \> one quarter of the total white matter);
- other central nervous system diseases (severe head trauma, tumors, subdural hematoma or other space occupying processes, etc.);
- seizure disorder;
- other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset...
- A current DSM-V diagnosis of active major depression, schizophrenia, or bipolar disorder
- Any suicidal ideation or suicidal behavior in the C-SSRS (C-SSRS score \> 0)
- Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the patient or put the...
- history of any kind of psychosis
- chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase \> 2.5 ULN);
- respiratory insufficiency;
- renal insufficiency (serum creatinine \>2 mg/dl) or creatinine clearance ≤ 30 mL/min according to Cockcroft-Gault formula). In case of creatinine clearance ≤30 mL/min, an alternative verification of the renal function...
- heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening);
- bradycardia (heart beat \ 95/min);
- hypertension (\>140/90 mm/Hg) or hypotension (\<90/60 mm/Hg) requiring treatment with more than three drugs;
- AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males \>450 and females \>470 msec);
- uncontrolled diabetes defined by HbA1c \>8.5;
- malignancies within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer;
- metastases;
- disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.);
- women who are fertile and of childbearing potential;
- chronic daily drug intake of ≥ 14 days or expected for ≥ 14 days:
- benzodiazepines, neuroleptics or major sedatives,
- antiepileptics,
- centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.),
- opioid containing analgesics,
- nootropic drugs (except Ginkgo Biloba);
- suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 500 ml of wine) per day, indicated by elevated mean corpuscular volume (MCV) above normal value at...
- suspected or known allergy to any components of the study treatments;
- hypersensitivity to the active substance rotigotine or to any of the excipients contained in the patches (according to SmPC).
- enrollment in another investigational study or intake of investigational drug within the previous three months or five times the half-life of the IMP/metabolites (whichever is longer)
- any condition, which, in the opinion of the investigator, makes the patient unsuitable for inclusion;
- if the patient is in any way dependent on the sponsor or the principal investigator or if the patient is accommodated in an establishment on judicial or administrative order.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.