Trial · NCT06702124
A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
NCT06702124, Phase 3, Recruiting, I.R.C.C.S. Fondazione Santa Lucia
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease. Trials, record NCT06702124. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06702124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
- NCT number
- NCT06702124
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 348 participants, estimated
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Conditions
- Alzheimer Disease
- Interventions
- Rotigotine 4Mg/24Hrs Patch, Placebo
- First posted
- 2024-11-22
- Last updated
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | From enrollment to the end of 24 weeks of treatment | FAB is a brief battery of six neuropsychological tasks designed to assess frontal lobe function |
| Secondary | 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 | The ADCS-ADL includes 23 items that were derived from a larger set of items describing performance of activities of daily living |
| Secondary | 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 | The MoCA is a brief, simple, and reliable screening test for AD. The test checks language, memory, visual and spatial thinking, reasoning, and orientation skills. |
| Secondary | 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 | The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care |
| Secondary | 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 | ADAS-cog assesses the level of cognitive dysfunction in AD. The ADAS-Cog14 consists of items from the following areas chosen for their sensitivity to AD: language; memory; praxis executive functions and orientation. |
| Secondary | 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 | The Apathy-Motivation Index was developed as a brief self-report index of apathy and motivation. |
| Other | 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 | All patients will undergo resting EEG recordings at the beginning and at the end of the experimental protocol with a 21 channels EEG. The neurophysiological measurement will be performed with the eyes closed and will last 3 minutes. |
| Other | 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 | Plasma samples will be collected according to the trail schedule |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06702124
GET https://conductscience.org/api/trials/v1/NCT06702124/registered