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

NCT06702124 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-01-22

No results posted yet for this study

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

Interventions

DRUG

Rotigotine 4Mg/24Hrs Patch

Rotigotine 4 mg/24Hrs administration for 24 weeks

DRUG

Placebo

Placebo administration for 24 weeks

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-07-31
Completion
2026-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702124 on ClinicalTrials.gov