Parkinson DiseaseNCT06275633
Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD
A study testing Levodopa in people with Parkinson Disease and Medication, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Medication, UPDRS
- What is being tested?
- Levodopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2019to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Treatment with anti-dopaminergic medication.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital Bispebjerg and Frederiksberg
Copenhagen, Capital Region, 2400
About this study
Official title: Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinson's Disease and Potential Correlation to Biomarkers.
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.
Read the detailed 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.
- Conditions
- Parkinson Disease, Medication, UPDRS, Motor Function, Cognitive Impairment, Depression
- Being tested
- Levodopa
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Depression, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
Medicine response
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor improvement
Unified Parkinson's disease rating scale, motor part (UPDRS-3) OFF medication compared to ON medication
Measured: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Secondary outcomes (1)
Cognitive function
Cognitive computer tests
Measured: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start19 Mar 2019
- Primary completion3 Dec 2021
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemette Lokkegaard, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275633
- Sponsor's protocol ID
- H-18055648
- Status last verified
- Feb 2024
- First submitted
- 14 Sep 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinson's Disease and Potential Correlation to Biomarkers.
- ClinicalTrials.gov ID
- NCT06275633
- Acronym / sponsor ID
- H-18055648
- Conditions
- Parkinson Disease, Medication, UPDRS, Motor Function, Cognitive Impairment, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Effect of levodopa | Experimental | Drug: Levodopa1. 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Dementia
- Treatment with anti-dopaminergic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevodopaMedicine response | Drug | Effect of levodopa |
Primary outcome
Motor improvement
Time frame: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Unified Parkinson's disease rating scale, motor part (UPDRS-3) OFF medication compared to ON medication
1 secondary outcome
Cognitive function
Time frame: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopa in people with Parkinson Disease and Medication, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor improvement (time frame: Baseline to end of Levodopa challenge test, approximately 3-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.