Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease

NCT06192823 | Completed Results

• 1 other identifier: 191683
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications

  The Parkinson's Disease-Related Pattern (PDRP) is a disease-specific metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects Parkinson's disease-related abnormalities in regional cerebral glucose metabolism. Individual PDRP scores represent standardized network expression values (z-scores; A Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.

  Day 1 and Day 8

• Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications

  The Parkinson's Disease Cognitive Pattern (PDCP) is a disease-related metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects metabolic abnormalities associated with cognitive dysfunction in Parkinson's disease. PDCP scores represent standardized network expression values (z-scores; Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease cognitive metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.

  Day 1 and Day 8

• Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout

  Finger tapping speed was measured using the Kinesia ONE wearable motion sensor system during standardized finger tapping tasks. Accelerometer data were used to generate quantitative finger tapping speed scores reflecting bradykinesia severity. Left and right finger tapping scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater bradykinesia severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.

  Day 1 through Day 8

• Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout

  Rest tremor severity was measured using the Kinesia ONE wearable motion sensor system during standardized tremor assessments. Accelerometer data were used to generate quantitative tremor severity scores. Left and right tremor scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater tremor severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.

  1 week

• Number of Participants With Adverse Events Related to the Medication Washout

  Number of participants experiencing an adverse event judged by the study neurologist to be related to the dopaminergic medication washout during the study period.

  1 week

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early-stage PD patients as defined by inclusion and exclusion criteria

You may qualify if:

• \*A clinical diagnosis of idiopathic PD. The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
• Clear and dramatic beneficial response to dopaminergic therapy (defined as demonstrating at least 30% improvement in parkinsonian motor signs based upon the UPDRS-III motor examination subscore, following the administration of their dopaminergic medications during the screening neurological examination)
• \*Hoehn and Yahr (H\&Y) stage II when off medication.
• Age between 50 and 75 years.
• Subjects must be on dopaminergic therapy for at least one year prior to the screening visit and less than four years prior to the completion of the washout period.
• Subjects must have a stable response to dopaminergic medication.
• Available for follow-up for the entire duration of the study.
• Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
• Subjects must agree to maintain a stable regimen, if deemed medically appropriate by the treating physician, of any psychotropic medications throughout the study.

You may not qualify if:

• \*Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
• Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)
• Dementia preceding motor symptoms
• Neurologic signs of upper motor neuron or cerebellar involvement
• Significant orthostatic hypotension unrelated to medications
• Unequivocal cortical sensory loss (i.e., graphesthesia, stereognosis with intact primary sensory modalities), clear limb ideomotor apraxia, or progressive aphasia
• Vertical supranuclear gaze palsy, or selective slowing of vertical saccades
• Unequivocal cerebellar abnormalities on examination, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (e.g., sustained gaze-evoked nystagmus, macro square wave jerks, hypermetric saccades)
• Documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (e.g., history of stroke, exposure to toxins, or encephalitis; or neuroleptic use within the past 6 months)
• \*The expert evaluating physician, based on the full diagnostic assessment, believes that an alternative syndrome is more likely than PD.
• \*Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
• \*Evidence of existing dyskinesias.
• \*Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
• \*Currently active diagnosis of a major psychiatric disorder
• Previous brain operation or injury.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Mallory Hacker
• Organization: Vanderbilt University Medical Center

mallory.hacker@vumc.org

6158757437

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: January 5, 2024
• Study Start: March 22, 2022
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-04

Locations

US (1)