Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD

NCT06275633 | Completed

• 1 other identifier: H-18055648
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa. Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response.

Conditions

Parkinson Disease; Medication; UPDRS; Motor Function; Cognitive Impairment; Depression; Impulsive; Levodopa

Outcome Measures

Primary Outcomes (1)

• Motor improvement

  Unified Parkinson's disease rating scale, motor part (UPDRS-3) OFF medication compared to ON medication

  Baseline to end of Levodopa challenge test, approximately 3-4 hours

Secondary Outcomes (1)

• Cognitive function

  Baseline to end of Levodopa challenge test, approximately 3-4 hours

Other Outcomes (3)

• Cognitive function

  Baseline

• Depressive symptoms

  Baseline

• Impulsivity

  Baseline

Study Arms (1)

Effect of levodopa

EXPERIMENTAL

1. Patients with PD are first being tested "off medication" 2. After examination OFF, the same group is being tested after adm of 200 mg Madopar Q

Drug: Levodopa

Interventions

Levodopa DRUG

Medicine response

Effect of levodopa

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: "Sex" means a person's classification as male or female based on biological distinctions.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of minimum 18
• Diagnosis of PD
• Be able to cooperate, understand and participate in the project
• Signed informed consent, including consent to being included in the Biobank

You may not qualify if:

• Dementia
• Treatment with anti-dopaminergic medication.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

University Hospital Bispebjerg and Frederiksberg

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Depression; Impulsive Behavior

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There will be a blinded assessment of videos of participants with Parkinson's Disease ON and OFF medication
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a prospective patient with Parkinson's Disease cohort. After acute levodopa challenge test patients with Parkinson's Disease are divided due to measured levodopa response and their self-rated medicine effect.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: February 23, 2024
• Study Start: March 19, 2019
• Primary Completion: December 3, 2021
• Study Completion: July 30, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

DK (1)