PPMI 2.0 Clinical -Establishing a Deeply Phenotyped PD Cohort

  • STATUS
    Recruiting
  • End date
    Dec 5, 2033
  • participants needed
    4500
  • sponsor
    Michael J. Fox Foundation for Parkinson's Research
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Updated on 19 February 2024
See if I qualify
parkinson's disease
bradykinesia
datscan
tremor
modafinil
genetic testing
muscle rigidity
resting tremor
alpha-synuclein
methyldopa

Summary

The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls

The overall goal of PPMI 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Description

PPMI 2.0 is a broad program, expanding the goals of the original PPMI study (NCT01141023), that includes this PPMI 2.0 Clinical protocol, as well as the PPMI 2.0 Remote, PPMI 2.0 Digital Applications and PPMI 2.0 Online protocols. All participants in PPMI 2.0 will be asked to be enrolled in all PPMI 2.0 protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI 2.0 participants may also be asked to participate in additional PPMI 2.0 companion studies (as they are developed), which may only involve a subset of PPMI 2.0 participants based on their cohort designation and/or site location.

Details
Condition Parkinson's Disease, Parkinson's Disease
Age 30years - 100years
Clinical Study IdentifierNCT04477785
SponsorMichael J. Fox Foundation for Parkinson's Research
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Enrolled in PPMI 2.0 Remote and based on risk criteria, or olfaction, and/or other assessments in the PPMI 2.0 Online protocol are eligible for PPMI 2.0 Clinical
Male or female age 60 years or older (except age 30 years or older for SNCA, or rate genetic mutations (such as Parkin or Pink1) participants)
Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging
Able to provide informed consent
Woman may not be pregnant, lactating or planning pregnancy during the study. ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to injection of DaTscan

Exclusion Criteria

Prodromal
Clinical diagnosis of PD, other parkinsonism, or dementia
Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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