A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease

NCT06702124 | Recruiting Phase 3 DMC

• 1 other identifier: EU CT Number:2023-504602-11-00
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alzheimer Disease

Keywords

Dopamine; Rotigotine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 24 in the FAB to evaluate efficacy of rotigotine in combination with rivastigmine on frontal lobe cognitive functions as compared to rivastigmine in combination with placebo.

  FAB is a brief battery of six neuropsychological tasks designed to assess frontal lobe function

  From enrollment to the end of 24 weeks of treatment

Secondary Outcomes (5)

• Change from Baseline to Week 24 in the ADCS-ADL to evaluate efficacy of rotigotine in combination with rivastigmine on autonomies of daily living as compared to rivastigmine in combination with placebo

  From enrollment to the end of 24 weeks of treatment

• Change from Baseline to Week 24 in the MoCA to evaluate efficacy of rotigotine in combination with rivastigmine on cognition as compared to rivastigmine in combination with placebo.

  From enrollment to the end of 24 weeks of treatment

• Change from Baseline to Week 24 in the CDR-SOB, to evaluate efficacy of rotigotine in combination with rivastigmine on cognition as compared to rivastigmine in combination with placebo

  From enrollment to the end of 24 weeks of treatment

• Change from Baseline to Week 24 in the ADAS-Cog14 to evaluate efficacy of rotigotine in combination with rivastigmine on memory functions as compared to rivastigmine in combination with placebo.

  From enrollment to the end of 24 weeks of treatment

• Change from Baseline to Week 24 in the AMI to evaluate efficacy of rotigotine in combination with rivastigmine on levels of apathy and motivation as compared to rivastigmine in combination with placebo.

  From enrollment to the end of 24 weeks of treatment

Other Outcomes (2)

• Change from Baseline to Week 24 in the EEG recordings, to evaluate effects of rotigotine in combination with rivastigmine or rivastigmine in combination with placebo on cortical oscillatory activity.

  From enrollment to the end of 24 weeks of treatment

• Change from Baseline to Week 24 in plasma Neurofilament light chain (NfL) and Aβ42 and p-tau concentrations to evaluate effects of rotigotine in combination with rivastigmine in combination with placebo on plasma biomarkers

  From enrollment to the end of 24 weeks of treatment

Study Arms (2)

Rotigotine 4 mg

EXPERIMENTAL

Rotigotine 4 mg/24 hours transdermal patch administration

Drug: Rotigotine 4Mg/24Hrs Patch

Placebo

PLACEBO COMPARATOR

Placebo transdermal patch administration

Drug: Placebo

Interventions

Rotigotine 4Mg/24Hrs Patch DRUG

Rotigotine 4 mg/24Hrs administration for 24 weeks

Rotigotine 4 mg

Placebo DRUG

Placebo administration for 24 weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify if:

• 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 study
• 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 physician/ neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver
• Failure to perform screening or baseline examinations

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Santa Lucia Foundation

Rome, Italy, 00179, Italy

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Giacomo Koch, Prof

CONTACT

+390651501181; g.koch@hsantlucia.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2024-11

Locations

IT (1)