Hunting for hidden clues: study seeks early warning signs of parkinson disease

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Individuals who report at least 3 of the following 4 risk factors at the protocol-specific website may be invited to the Screening Examination. All subjects must have ability to provide their own consent for participation in the study. Otherwise eligible candidate participants who are taking medications that would interfere with the scientific results may be included, if (1) the medications are held temporarily or safely substituted for, and (2) the medications are held while the participants are inpatients. The prescribing physician will be contacted, with the participant's permission, if withholding or substituting medication is considered. 1. Genetic Risk: A positive family history (one immediate or more than one non-immediate family member with PD) or positive genetic testing (e.g., LRRK2, alpha-synuclein, glucocerebrosidase) satisfies this risk factor criterion. 2. Olfactory Dysfunction: Olfactory dysfunction reported at the protocol-specific website satisfies this criterion. This may be confirmed by the UPSIT sent by mail prior to the Screening Examination. 3. REM Behavior Disorder (RBD): To satisfy this risk factor criterion, the individual must have movements of the body or limbs associated with dreaming and at least one of the following: potentially harmful sleep behavior, dreams that appear to be acted out, and sleep behavior that disrupts sleep continuity. 4. Orthostatic Hypotension (OH): To satisfy this risk factor criterion, the individual reports symptoms of orthostatic hypotension or having orthostatic hypotension at the protocol-specific website. This may be confirmed by orthostatic vital signs prior to the Screening Examination. EXCLUSION CRITERIA: 1. Age: People younger than 18 years old or older than 70 years old are excluded. 2. Risk: A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. This includes the risks associated with air travel to the NIH. A candidate subject may be excluded from the study if, in the opinion of the Principal Investigator or Clinical Director, the medical risk outweighs the potential scientific benefit. An example of such risk is inability to travel safely to the NIH Clinical Center, in Bethesda, Maryland, due to a neurological disorder associated with frequent falls. 3. Disqualifying Conditions: A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are insulin-dependent diabetes, hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, ventricular arrhythmias, and symptomatic coronary heart disease. * Unable to Provide Consent: Persons who are unable to provide their own consent (e.g., due to dementia) are excluded. * MRI: Persons who are unable to undergo MRI safely, due to implanted metal, are excluded from the MRI procedure. * Safe Travel: A candidate participant is excluded if the person is unable to travel safely to the NIH Clinical Center, in Bethesda, Maryland, such as due to a neurological disorder associated with frequent falls. 4. Medications: A candidate subject is excluded if clinical considerations require continued treatment with a drug likely to interfere with the scientific results. Chronic, ongoing use of drugs such as tricyclic antidepressants that affect the clinical laboratory results exclude candidate subjects. People with known or suspected allergy or hypersensitivity to any test drug are excluded. Candidate subjects are not to discontinue any medications before discussion with the Principal Investigator, Research Nurse, Nurse Practitioner, or Clinical Fellow. Temporary discontinuation of serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine (Effexor), duloxetine (Cymbalta), or des-venlafaxine (Pristiq) can result in rapid rebound of depression or anxiety, and so treatment with SNRIs is exclusionary. 5. Herbal Medicines and Dietary Supplements: If a subject wishes to continue herbal medicines or dietary supplements while on study, but a search of the available medical identifies drug effects that are known or expected to interfere with the experimental results, then the subject may be excluded, at the discretion of Principal Investigator 6. Practical Limitations: People in whom we feel it would be difficult to insert a catheter into a vein may be excluded. People who are not expected clinically to tolerate lying still supine during the testing will be excluded. 7. Pregnancy: Pregnant or lactating women are excluded