Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

A Phase 2 study testing DaTscan in people with Parkinson Disease, run by Ken Marek, MD at 34 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: DaTscan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 952 participants
Where: 34 sitesin 11 countries
Study dates: Jun 2010to 30 Jun 2020
Phase: Phase 2
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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Parkinson Disease (PD) Subjects:
A diagnosis of Parkinson disease for 2 years or less at Screening.
Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.
Not expected to require PD medication with at least 6 months from Baseline.
Male or female age 30 years or older at time of PD diagnosis.
Healthy Control (HC) Subjects:

Show all 13Show fewer

Male or female age 30 years or older at Screening.
Male or female age 45 years or older at baseline with LRRK2 or GBA mutation and/or first degree relative with a LRRK2 or GBA mutation or
Male or female age 30 years or older at baseline with a SNCA mutation and/or a first degree relative with a SNCA mutation.
Unaffected subjects at high risk of LRRK2, GBA or SNCA mutation due to first degree relative with a LRRK2, GBA or SNCA mutation may choose either to be informed of the results or remain unaware of the results.
Unaffected subjects from an ethnic or geographic group knkown to have relatively high risk of LRRK2, GBA or SNCA mutation such as people of Ashkenazi Jewish or Basques descent) and who have a family member (either alive or deceased) who has/had PD must be willing to be informed of their own testing results.
Willingness to undergo genetic testing
For subjects taking any of the following drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to DatSCAN imaging.

Who cannot join

Parkinson Disease (PD) Subjects:
Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication.
Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline.
Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days.
Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.

Show all 60Show fewer

If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
Use of investigational drugs within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
Healthy Control (HC) Subjects:
Current or active neurological disorder.
First degree relative with idiopathic PD (parent, sibling, child).
MoCA score < 26.
Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ) or amphetamine type medications.
Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
Use of other investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
SWEDD Subjects:
All PD criteria apply, as above, except a SWEDD subject must have confirmation from imaging core that screening dopamine transporter SPECT scan shows no evidence of dopamine transporter deficit or if applicable a VMAT-2 PET scan shows no evidence of vesicular monoamine transporter deficit.
Prodromal Subjects:
Inclusion Criteria (Prodromal Subjects) 4.2.7.1. Subjects must have at least one of the following characteristics:
Hyposmia:
Male or female age 60 years or older
Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender
REM Behavior Disorder (RBD):
Male or female age 60 years or older
Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD
LRRK2:
Male or female age 60 years or older
Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN).
Current or active clinically significant neurological disorder or psychiatric disorder (in the opinion of the Investigator).
GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).
STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.
A clinical diagnosis of dementia63 as determined by the investigator (Appendix 1).
A clinical diagnosis of Parkinson disease at the Screening visit as determined by the Investigator.
Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
Genetic Cohort: Parkinson Disease Subjects - Inclusion:
Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting remor or bradykinesia) or either asymmetric resting tremor or asymmetric bradykinesia.
A diagnosis of Parkinson Disease for 7 years or less at screening.
Hoehn and Yahr state <4 at baseline
Male or female age 18 years or older
Willingness to undergo genetic testing and to be informed of genetic testing results.
Confirmation of mutation in LRRK2, GBA or SNCA
For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DatSCAN(TM) imaging.
Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis or clinically significant coagulopathy or thrombocytopenia.
Genetic cohort - Unaffected Individuals
A clinical diagnosis of PD
Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis or clinically significant coagulopathy or thrombocytopenia.
Genetic Registry - Inclusion:
Individual with a LRRK2, GBA or SNCA mutation and/or a first degree relative with a LRRK2, GBA or SNCA mutation.
Male or female age 18 years or older
Willingness to undergo genetic testing, but may choose either to be informed of the results or remain unaware of the results.

Trial locations and contacts

34 sites in 11 countries.

Country

City, postcode or hospital

34 sites in 11 countries

United States21 sites

Emory University School of Medicine
Atlanta, Georgia, 30329
John Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Parkinson's Disease& Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486
Boston University
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati/Cincinnati Children's Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093-0948
Institute For Neurodegenerative Disorders
New Haven, Connecticut, 06510
Beth Israel Medical Center
New York, New York, 10003
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health &Science University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14620
University of California, San Francisco
San Francisco, California, 94115
Univ of Washington and VA Puget Sound Health Care System
Seattle, Washington, 98104
Banner Research Institute
Sun City, Arizona, 85351
The Parkinson's Institute
Sunnyvale, California, 94085
University of South Florida
Tampa, Florida, 33606

Other trials in United States

Germany2 sites

Paracelsus-Elena Klinik
Kassel, 34128
University of Tuebingen
Tübingen, 72076

Other trials in Germany

Italy2 sites

Universita Federico II
Naples, 80131
University of Salerno
Salerno, 84131

Other trials in Italy

Spain2 sites

Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Donostia
Donostia / San Sebastian, 20014

Other trials in Spain

Australia1 site

Macquarie University
Sydney, NSW2109

Other trials in Australia

Austria1 site

Innsbruck Medical University
Innsbruck, 6020

Other trials in Austria

France1 site

Hospital Pitie-Salpetriere
Paris, 75013

Other trials in France

Greece1 site

Foundation for Biomedical Research of the Academy of Athens
Athens, 11523

Other trials in Greece

Israel1 site

Tel Aviv Sourasky Medical Center
Tel Aviv, 64239

Other trials in Israel

Norway1 site

St. Olavs Hospital
Trondheim, 7006

Other trials in Norway

United Kingdom1 site

Imperial College London
London, W12 0NN

Other trials in United Kingdom

About this study

Official title: The Parkinson's Progression Markers Initiative (PPMI)

The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Read the detailed description

Amendment 14 - 26-Mar-2018 Revised to reflect the implementation of PPMI Wearables and Sensor Study Companion Protocol

Amendment 13 - 20-Nov-2017 Extension of study duration until 2023 for all cohorts (except Genetic Registry).

Amendment 12 - 01-Jun-2017 Planned date of trial extended to September 30, 2020 Ceasing new enrollments into the Genetic Registry for LRRK2 and GBA subjects Added Sensor - PPMI Companion Study Allow for consent to share contact information with FOUND team at any visit. Incorporation of Parkinson's Disease Risk Factor Questionnaire (PD-RFQ) into FOUND.

Amendment 11 - 01-Apr-2016 Added the collection of peripheral blood mononuclear cells (PBMC) from blood samples at interim visits.

Addition of PPMI Pathology Core/PPMI Brain and Tissue Bank Addition of Gait Assessment Companion Study (Select PPMI sites - Genetic Cohort only) Testing for additional GBA mutations - previously testing involved testing only for the GBA N370S mutation; however, going forward, testing will include tests for additional GBA mutations that are identified as being associated with certain ancestry.

Amendment 10 - 05-Oct-2015 Extended study period for PD and Healthy Control subjects through 8 years. For Prodromal subjects (RBD and Hyposmic) added iPSC companion study.

Amendment 9 - 01-Nov-2014 Addition of GBA throughout to document additional testing for GBA mutation. Allocation of subjects in Genetic Cohort and Genetic Registry revised to account for inclusion of GBA subjects.

Amendment 8 - 12-May-2014 Companion Protocols: skin biopsy/stem cell; Amyloid Imaging 18F Florbetaben; Family History Sub-Study; FOUND in PPMI registry. More detailed description of new procedures including: Advance directive for clinical research participation; Extension of study period (for SWEDDs with positive scans at Yr. 2) by continuing or re-inviting to study and followed (as per PD subjects through Month 60); Objective Parkinson Disease Measurement (OPDM) finger tapping measurement.

Amendment 7 - 14-Oct-2013 Pre-Screening Prodromal - RBD clarifications Pre-Screening Genetic Cohort - clarified Assessments/tests clarified, including addition of consent (or withdrawal of consent, if applicable) for future contact about future studies and PD family history data collection for Genetic cohort subjects as selected visits.

Amendment 6 - 29-May-2013 Genetics Coordination Core is added to study. The GCC included Genetic Cohort PD Subjects, Genetic Cohort Unaffected Subjects and Genetic Registry Subjects.

Amendment 5 - 27-Nov-2012 Olfactory and RBD subjects added as the Prodromal cohort.

Amendment 4 - 30-Mar-2012 Addition of 18F-AV-133 VMAT-2 PET Imaging for participating U.S. sites and Australia. (Refer to 18F-AV-133-PPMI companion protocol).

Number of sites increased from 21 to 24. Addition of cognitive categorization and diagnostic features assessments.

Amendment 3 - 15-Jul-2011 Addition of SWEDD subjects to study design. Blood Sampling Advisement to collect research samples in a fasted state.

Amendment 2 - 19-May-2011 Changed visit window from 30 days to 45 days for Baseline visit to be completed.

Section on DAT and SPECT Imaging - section changed to account for subject travel to the Institute for Neurodegenerative Disorders to conduct SPECT scanning and injection of either DaTSCAN or BCIT.

Main Protocol - PPMI will be a five-year natural history study (a minimum of 3-year involvement for each subject) of de novo idiopathic PD patients and healthy controls. This study will also include a SWEDD (subjects without evidence of dopaminergic deficit)and Prodromal populations.

All subjects will be comprehensively assessed at baseline and every three to six months thereafter. Subjects will undergo clinical (motor, neuropsychiatric and cognitive) and imaging assessments and will donate blood, urine, and cerebral spinal fluid (CSF). A blood sample for DNA will be collected. Data will be collected by each site under uniformly established protocols and data will be analyzed and stored at designated core facilities.

Conditions: Parkinson Disease
Being tested: DaTscan
Keywords: Parkinson, Bio-markers, Neurodegenerative disorder, Imaging, Prodromal
Medical subject headings: Parkinson Disease, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaTscanDrug
Also called Ioflupane

Study groups in NCT01141023
Study group	Role	What they receive
Datscan SPECT Imaging	Experimental	Subjects will b injected with 3-5 mCi of dopamine transporter. Within a 4 hour (+/- 30 minutes) window following the injection, subjects will undergo SPECT imaging on the camera. Receives: Drug: DaTscan

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Rates of Change
The mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients, and where appropriate the comparison of these rates between PD patient subsets and between various subsets (including, but not limited to: PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy controls) at study intervals ranging from 3 months to 36 months. Specific examples of outcomes include MDS-UPDRS, dopamine transporter imaging striatal uptake, vesicular monoamine transporter type-2 uptake, and serum and CSF alpha-synuclein. PD patient subsets may be defined by baseline assessments, genetic mutations, progression milestones and/or rate of clinical, imaging, or biomic change.
Measured: Baseline to 156 months

Secondary outcomes (5)

Comparison between Rates of Change
Comparison between the rates of change in the mean of clinical, imaging and biomic outcomes in various subsets (including, but not limited to: early PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation vs. healthy controls)
Measured: Study intervals ranging from 3 months to 156 months
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets (
Including, but not limited to: early PD patients, healthy subjects, PD vs SWEDDs, PD vs prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy subjects.
Measured: study intervals ranging from baseline to 156 months.
Predictive Value
To establish the predictive value of early clinical non-motor features, baseline imaging and biomic outcomes for future course of disease.
Measured: Baseline to 156 months
To examine the proportion of SWEDD subjects that have a change in their clinical management at 24 months
SWEDD Clinical Diagnosis and Management Questionnaire.
Measured: Baseline to 156 Months
Exploratory Analysis
Exploratory analysis to estimate the percentage of Prodromal subjects with one or more risk characteristics [hyposmia (<10th percentile for age and gender), RBD, or LRRK2, GBA or SNCA genetic mutation, and baseline DaTSCAN binding showing minimal to moderate DAT deficit] that phenoconvert to PD within 2 years, and an exploratory analysis to examine whether the baseline DaTSCAN binding or progression of clinical, imaging, or biospecimen markers may predict those subjects likely to phenoconvert.
Measured: Baseline to 156 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201030 Jun 2020

First posted10 Jun 2010 (estimated)
Study startJun 2010
Primary completion30 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
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 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 952 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141023
Sponsor's protocol ID: PPMI-001
Acronym: PPMI
Status last verified: Nov 2023
First submitted: 8 Jun 2010
Last updated: 14 Nov 2023
Results posted: No
Data monitoring committee: Yes

Publications

Seyedmirzaei H, Nakhostin-Ansari A, Rafiei N, Khaboushan AS, Abdolalizadeh A. The relationship between physical activity levels and measures of cognition and disease severity in prodromal Parkinson's disease: A longitudinal study. BMC Neurol. 2026 Jul 2. doi: 10.1186/s12883-026-05077-z. Online ahead of print.
PubMed 42393590
Tsukita K, Kikuya A, Yoshimura K, Nakanishi E, Matsumoto R, Takahashi R. Temporal Dynamics and Cross-Sectional and Longitudinal Factors Associated With Motor Reserve and Outcome in Patients With Parkinson Disease. Neurology. 2026 Jan 27;106(2):e214475. doi: 10.1212/WNL.0000000000214475. Epub 2025 Dec 26.
PubMed 41453126
Liu Y, Chen M, Chen P, Lin X, Chen S, Liu C, Wang D, Deng H, Li Q, Wu Y. Machine learning-based stratification of mild cognitive impairment in Parkinson's disease: a multicenter cross-sectional analysis. BMC Med Inform Decis Mak. 2025 Oct 15;25(1):384. doi: 10.1186/s12911-025-03215-0.
PubMed 41094519
Tuena C, Repetto C, Ibanez A, Magni G, Stramba-Badiale M, Riva G. Embodied concepts in Parkinson's disease: Insights from fruits versus animals semantic fluency impairments. Neuropsychology. 2025 Oct;39(7):610-618. doi: 10.1037/neu0001026. Epub 2025 Jul 24.
PubMed 40705614
Pisani S, Velayudhan L, Aarsland D, Ray Chaudhuri K, Ballard C, Ffytche D, Bhattacharyya S. Decline in striatal binding ratio associated with accelerated decline in performance on symbol digit modality but not MoCA in Parkinson's Disease Psychosis. BMJ Ment Health. 2025 Mar 31;28(1):e301430. doi: 10.1136/bmjment-2024-301430.
PubMed 40164470
Vijayakumari AA, Saadatpour L, Floden D, Fernandez H, Walter BL. Neuroanatomical heterogeneity drives divergent cognitive and motor trajectories in Parkinson's disease subtypes. J Neurol Sci. 2025 Jan 15;468:123335. doi: 10.1016/j.jns.2024.123335. Epub 2024 Dec 2.
PubMed 39644799
Li Y, Zhang T, Wang C, Geng L, Liu T, Lu T, Ju S. The Impact of Sleep Disorders on Glymphatic Function in Parkinson's Disease Using Diffusion Tensor MRI. Acad Radiol. 2025 Apr;32(4):2209-2219. doi: 10.1016/j.acra.2024.11.030. Epub 2024 Dec 2.
PubMed 39627057
Pisani S, Gosse L, Aarsland D, Ray Chaudhuri K, Ballard C, Ffytche D, Velayudhan L, Bhattacharyya S. Parkinson's disease psychosis associated with accelerated multidomain cognitive decline. BMJ Ment Health. 2024 Jul 23;27(1):1-10. doi: 10.1136/bmjment-2024-301062.
PubMed 39043465
Park M, Lee YG. Association of Family History and Polygenic Risk Score With Longitudinal Prognosis in Parkinson Disease. Neurol Genet. 2023 Dec 8;10(1):e200115. doi: 10.1212/NXG.0000000000200115. eCollection 2024 Feb.
PubMed 38169864
Tsukita K, Sakamaki-Tsukita H, Kaiser S, Zhang L, Messa M, Serrano-Fernandez P, Takahashi R. High-Throughput CSF Proteomics and Machine Learning to Identify Proteomic Signatures for Parkinson Disease Development and Progression. Neurology. 2023 Oct 3;101(14):e1434-e1447. doi: 10.1212/WNL.0000000000207725. Epub 2023 Aug 16.
PubMed 37586882
Wang C, Zhou C, Guo T, Jiaerken Y, Yang S, Xu X, Hu L, Huang P, Xu X, Zhang M. Current coffee consumption is associated with decreased striatal dopamine transporter availability in Parkinson's disease patients and healthy controls. BMC Med. 2023 Jul 25;21(1):272. doi: 10.1186/s12916-023-02994-5.
PubMed 37491235
Kim R, Kang N, Byun K, Park K, Jun JS. Prognostic significance of peripheral neutrophils and lymphocytes in early untreated Parkinson's disease: an 8-year follow-up study. J Neurol Neurosurg Psychiatry. 2023 Dec;94(12):1040-1046. doi: 10.1136/jnnp-2022-330394. Epub 2023 Jul 14.
PubMed 37451695
Weintraub D, Picillo M, Cho HR, Caspell-Garcia C, Blauwendraat C, Brown EG, Chahine LM, Coffey CS, Dobkin RD, Foroud T, Galasko D, Kieburtz K, Marek K, Merchant K, Mollenhauer B, Poston KL, Simuni T, Siderowf A, Singleton A, Seibyl J, Tanner CM; Parkinson's Progression Markers Initiative. Impact of the Dopamine System on Long-Term Cognitive Impairment in Parkinson Disease: An Exploratory Study. Mov Disord Clin Pract. 2023 Apr 25;10(6):943-955. doi: 10.1002/mdc3.13751. eCollection 2023 Jun.
PubMed 37332638
Brumm MC, Pierz KA, Lafontant DE, Caspell-Garcia C, Coffey CS, Siderowf A, Marek K. Updated Percentiles for the University of Pennsylvania Smell Identification Test in Adults 50 Years of Age and Older. Neurology. 2023 Apr 18;100(16):e1691-e1701. doi: 10.1212/WNL.0000000000207077. Epub 2023 Feb 27.
PubMed 36849448
Kim R, Park S, Yoo D, Jun JS, Jeon B. Association of Physical Activity and APOE Genotype With Longitudinal Cognitive Change in Early Parkinson Disease. Neurology. 2021 May 11;96(19):e2429-e2437. doi: 10.1212/WNL.0000000000011852. Epub 2021 Mar 31.
PubMed 33790041

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Parkinson's Progression Markers Initiative (PPMI)
ClinicalTrials.gov ID: NCT01141023
Acronym / sponsor ID: PPMI / PPMI-001
Conditions: Parkinson Disease
Keywords: Parkinson, Bio-markers, Neurodegenerative disorder, Imaging, Prodromal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 952 participants (actual)
Lead sponsor: Ken Marek, MDUniversity, hospital or other
Collaborators: Institute for Neurodegenerative Disorders
Study start: Jun 2010 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 10 Jun 2010 (estimated)
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.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Detailed description