Measuring Parkinson's Disease Progression

NCT03205956 | Completed Phase 1 FDA Drug

• 1 other identifier: 009
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD). Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD progression, and accelerate the pace of research.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; PD; levodopa

Outcome Measures

Primary Outcomes (1)

• Ke measured by phMRI

  Effect site rate constant measured by serum levodopa concentrations and regional cerebral blood flow. Note, there are no outcome measures relevant to clinical care. This is not a placebo-controlled treatment study.

  2 hours

Secondary Outcomes (1)

• Side effect ratings

  2 hours

Study Arms (1)

PD Group

EXPERIMENTAL

A broad range of Parkinson's disease severity and disease duration. Some subjects will not be treated currently with levodopa, and thus likely will be early in the disease process.

Drug: Levodopa

Interventions

Levodopa DRUG

At least 1 hour after 200mg carbidopa p.o., each subject will receive an intravenous solution of levodopa in saline at a rate based on age and body mass according to the "final dose" described in Black et al 2003.The total dose for a 70-year-old, 70kg subject will be approximately 65mg. Subjects with untreated PD will then take 6 ± 1 weeks of clinically dosed oral carbidopa-levodopa tablets for clinical purposes and then repeat the carbidopa plus intravenous levodopa dose as above.

Also known as: Carbidopa

PD Group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-79 at screening
• Meet accepted diagnostic criteria for Parkinson disease

You may not qualify if:

• Deep brain stimulator (DBS)
• Pregnancy
• Patients taking a dopamine antagonist (like quetiapine) or dopamine partial agonist (like aripiprazole)
• Metal in the head or eye, or other contraindication to MRI
• Claustrophobia
• Serious neurologic disease other than PD
• Head trauma with loss of consciousness for more than 5 minutes
• Severe or unstable systemic illness
• Certain psychiatric illnesses (dementia, psychosis, current major depression)
• Current alcohol use disorder
• Subjects who feel that going without nicotine for 3-4 hours would be uncomfortable
• Currently taking an extended-release formulation of a dopamine agonist (like Mirapex ER or Requip XL)

Sponsors & Collaborators

• Kevin J. Black, MD: lead
• The Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Washington University School of Medicine, Movement Disorders Center

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Black KJ, Carl JL, Hartlein JM, Warren SL, Hershey T, Perlmutter JS. Rapid intravenous loading of levodopa for human research: clinical results. J Neurosci Methods. 2003 Jul 15;127(1):19-29. doi: 10.1016/s0165-0270(03)00096-7.

  PMID: 12865145 BACKGROUND

• Siddiqi SH, Abraham NK, Geiger CL, Karimi M, Perlmutter JS, Black KJ. The Human Experience with Intravenous Levodopa. Front Pharmacol. 2016 Jan 6;6:307. doi: 10.3389/fphar.2015.00307. eCollection 2015.

  PMID: 26779024 BACKGROUND

• Koller JM, Vachon MJ, Bretthorst GL, Black KJ. Rapid Quantitative Pharmacodynamic Imaging with Bayesian Estimation. Front Neurosci. 2016 Apr 8;10:144. doi: 10.3389/fnins.2016.00144. eCollection 2016.

  PMID: 27092045 BACKGROUND

• Black KJ, Acevedo HK, Koller JM. Dopamine Buffering Capacity Imaging: A Pharmacodynamic fMRI Method for Staging Parkinson Disease. Front Neurol. 2020 May 6;11:370. doi: 10.3389/fneur.2020.00370. eCollection 2020.

  PMID: 32477245 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Carbidopa

Condition Hierarchy (Ancestors)

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

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; Methyldopa; Hydrazines

Study Officials

• Kevin J Black, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All participants receive oral carbidopa before, and i.v. levodopa during brain imaging, to measure regional cerebral blood flow responses to levodopa.

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: October 19, 2017
• Primary Completion: October 18, 2019
• Study Completion: October 19, 2019
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 36 months after completion of last participant
• Access Criteria: Public

Locations

US (1)