UPDRS Clinical Trial - Behavioural Profiling of Disease-related Cognitive

Status Completed

Clinical Trial 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.

Clinical Trial Description

The patients with Parkinson's Disease will be included from the outpatient clinic at the Department of Neurology at Bispebjerg Frederiksberg Hospital and healthy controls will be found among relatives or volunteers through research ads. Patients will be asked to pause dopaminergic medication for 6 half times.Then a baseline examination will be performed in the morning in a non-medicated state (OFF), using Unified Parkinson's disease rating Scale (UPDRS), the MOntreal Cognitive Assessment (MoCA) and computerized cognitive testing. Baseline screening for depression with Beck Depression Inventory (BDI) and for impulsivity with Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP). An acute levodopa challenge will be performed with patients receiving 200/25 mg dispersible levodopa/benserazide. After an hour UPDRS and cognitive computerized tests are repeated. This is estimated to take about 3½ hours to complete. In healthy controls a neurological examination, BDI and MoCA will pe performed. The UPDRS motor test is videotaped. A specialist will later evaluate the motor function blinded. The participants will be asked to participate in the Bispebjerg Frederiksberg (BFH) BioBank, BFH-2017-114, (ISuite nr.: 05991) at Bispebjerg Frederiksberg Hospital for future research. An exact calculation of power is difficult to calculate as the project includes a broad range of correlations. Numeric data will be analysed using the Student's t-test (when normal distribution is met) or Wilcoxon rank sum test (when normal distribution is not met). Binary data will be analysed using the Fishers exact test. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06275633
Study type	Interventional
Source	University Hospital Bispebjerg and Frederiksberg
Contact
Status	Completed
Phase	N/A
Start date	March 19, 2019
Completion date	July 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04977232` - Adjunctive Game Intervention for Anhedonia in MDD Patients	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting	`NCT04043052` - Mobile Technologies and Post-stroke Depression	N/A
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT06011681` - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed	`NCT04476446` - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives	Phase 3
Recruiting	`NCT02783430` - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease	Phase 2/Phase 3
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04598165` - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Recruiting	`NCT05234476` - Behavioral Activation Plus Savoring for University Students	N/A
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Enrolling by invitation	`NCT03276585` - Night in Japan Home Sleep Monitoring Study
Terminated	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms