Prevent Cognitive Decline in GBA-associated Parkinson's Disease
NCT07055087, Phase 2, Recruiting, University Hospital Tuebingen
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prevent Cognitive Decline in GBA-associated Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT07055087 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital Tuebingen | ClinicalTrials.gov |
| Conditions | Parkinson's Disease | ClinicalTrials.gov |
| Interventions | Prasinezumab, Sodium Chloride | ClinicalTrials.gov |
| First posted | 2025-07-08 | ClinicalTrials.gov |
| Last updated | 2026-10-23 | ClinicalTrials.gov |
Registered outcomes 44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Parkinson's Disease Cognitive Composite Score (PDCCS) | week 104 | To assess the efficacy of prasinezumab compared with placebo on cognitive function at week 104 measured by the Parkinson's Disease Cognitive Composite Score (PDCCS). Composite score that includes the following cognitive tests: * LNS (Attention) * Derived-Sem. Fluency-Animal T-Score (Executive function) * Derived-Delayed Recall T-Score (Memory) * MoCA (Global cognition) Per single Test: Group Mean and Standard Deviation (SD) at Baseline = reference ZBaseline = (xBaseline - Group MeanBaseline) / SDBaseline ZFollow-up = (xFollow-up - Group MeanBaseline) / SDBaseline Mean of Z-Scores of relevant Tests per Patient per Visit Min-Max: n.a. (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function (MoCA_z) | week 104 | Cognitive function measured by MoCA\_z (Montreal Cognitive Assessment demographically-corrected z-value) Min-Max: 0 - 30 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | PD-MCI | week 104 | Percentage of participants with diagnosis of PD-MCI defined by MDS Level II criteria | ClinicalTrials.gov |
| Secondary | PDD | week 104 | Percentage of participants with diagnosis of PDD | ClinicalTrials.gov |
| Secondary | MDS-UPDRS I-IV | week 104 | International Parkinson and Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) part I-IV Min-Max: 0 - 272 (lower values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Levodopa-equivalent dosage | week 104 | Levodopa-equivalent dosage \[mg\] | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: Attention and working Memory (1/2) | week 104 | Cognitive function per cognitive domain: Attention and working Memory: Trail Making Test Part A (TMT A) Min-Max: 0 - 100 seconds (lower values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: Attention and working Memory (2/2) | week 104 | Cognitive function per cognitive domain: Attention and working Memory: Wechsler Adult Intelligence Scale (WAIS) IV: Letter-Number Span (LNS) Min-Max: 0 - 21 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: executive (1/3) | week 104 | Cognitive function per cognitive domain: Executive: Verbal Fluency (animal fluency) Score: number of named animals (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: executive (2/3) | week 104 | Cognitive function per cognitive domain: Executive: Stroop interference Min-Max: 0 - n.a. (lower values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: executive (3/3) | week 104 | Cognitive function per cognitive domain: Executive: Trail Making Test (TMT) part B Min-Max: 0 - 300 seconds (lower values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: memory (1/2) | week 104 | Cognitive function per cognitive domain : Memory: Hopkins verbal learning test (HVLT) Delayed Recall Min-Max: 0-12 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: memory (2/2) | week 104 | Cognitive function per cognitive domain : Memory: Wechsler Memory Scale (WMS): logical memory I Min-Max: 0 - 50 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: visuospatial (1/2) | week 104 | Cognitive function per cognitive domain: Visuospatial: Benton's Judgment of Line Orientation Min-Max: 0 - 30 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: visuospatial (2/2) | week 104 | Cognitive function per cognitive domain: Visuospatial: Hooper Visual Organization Test Min-Max: 0 - 30 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: language (1/2) | week 104 | Cognitive function per cognitive domain: Language: Boston naming Min-Max: 0 - 60 (higher values mean a better outcome) | ClinicalTrials.gov |
| Secondary | Cognitive function per cognitive domain: language (2/2) | week 104 | Cognitive function per cognitive domain: Language: Wechsler Adult Intelligence Scale (WAIS) IV: similarities Min-Max: 0 - 33 (higher values mean a better outcome) | ClinicalTrials.gov |
| Other | Exploratory: cognitive function (MoCA_z) | week 104 | Cognitive function measured by PDCCS in the prasinezumab and placebo group separately compared to MoCA\_z values (Montreal Cognitive Assessment demographically-corrected z-value) PDCCS is a composite score (see primary endpoint for details) | ClinicalTrials.gov |
| Other | Exploratory: Cognitive function (MoCA ≥ 26) | week 104 | Cognitive function measured by PDCCS in the prasinezumab versus placebo group in participants who were cognitively normal at baseline as defined by MoCA ≥ 26. PDCCS is a composite score (see primary endpoint for details) | ClinicalTrials.gov |
| Other | Exploratory: Cognitive function (PD-MCI) | week 104 | Cognitive function measured by PDCCS in the prasinezumab versus placebo group in participants who had PD-MCI at baseline as defined by MoCA ≤ 25. PDCCS is a composite score (see primary endpoint for details) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Line Angle Matching | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)