Cannabidiol

Change from baseline to Week 104 in the positive symptom subscale score (P1-P4) of the Comprehensive Assessment of At-Risk Mental States (CAARMS). Higher scores indicate greater symptom severity.

Effects of CBD on in-vivo glutamatergic levels within mesocorticolimbic brain regions using Proton-Magnetic resonance spectroscopy.

Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during the cue reactivity task at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.

Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.

All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB.

Measured in millimeters (mm)

Data on cognitive function was collected using the List Sorting Working Memory Test from the NIH Toolbox. Data was collected on working memory performance, which was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug.

Severity of each specific adverse event was scored as 0=no adverse event, 1=mild adverse event, 2=moderate adverse event, and 3=sever adverse event. The range of severity is 0-3. Higher scores mean a worse outcome. The severity was expressed as mean (standard deviation).

Orthostatic blood pressure will be monitored at each study visit.

A physical exam will be performed at each study visit.

EKG will be performed at each study visit.

Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit.

Assessing the proportion of subjects that drop out of the study due to study drug intolerance.

There are four parts: Part I (Non-motor experiences of daily living, scores range 0-52), Part II (motor experiences of daily living, scores range 0-52), Part III (motor examination, scores range 0-132) and Part IV (motor complications scores range 0-24). Subscales are summed to a total score, ranging 0-260. Higher scores mean a worse outcome.

MoCA - is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual -constructional skills, conceptual thinking, calculation. Scores range 0-30. Higher values represent a better outcome.

This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome.

Assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders. It has proven to be sensitive to change and has been employed to capture treatment related behavioral.Total NPI scores range 0-120. Higher values represent a worse outcome.

This includes 8 items that assess severity of depression. Score range 8-40. Higher values represent a worse outcome.

A valid, reliable, short scale that is used to evaluate night time sleep problems in PD. Scores range 0-18. Higher values represent a worse outcome.

10-item, patient self-rating instrument assessing the subject's sleep behavior with short questions that have to be answered by either "yes" or "no". Scores range 0-13. Higher values represent a worse outcome.

8 items that assess severity of emotional and behavioral dyscontrol. Scores range 8-40. Higher values represent a worse outcome.

This will assess severity of pain. Scores range 3-15. Higher scores represent a worse outcome.

To measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. Total QUIP-RS scores were summed by 6 subscores (gambling 0-16, Sex 0-16, Buying 0-16, Eating 0-16, Hobbyism-punding 0-32, and PD Medication use 0-16), range 0-112. Higher scores represent a worse outcome.

A self-report 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. Scores range 9-63. Higher values represent a worse outcome.

This encompasses a ten-question instrument for measuring severity of restless legs syndrome (RLS). Score range 0-40. Higher values represent a worse outcome.

To evaluate involuntary movements often associated with treated Parkinson's disease. Total UDysRS scores is the sum of historical sub-scores (0-60) and objective sub-score (0-44). Total scores range 0-104. Higher values represent a worse outcome.

Measurement of brain activity using the Blood Oxygenation Level Dependent (BOLD) signal Neural (BOLD) functional response to acute stress and network hierarchy in resting state functional connectivity. BOLD response will measure neural activity during stress conditions as compared to rest and control conditions

Concentration of brain chemicals (N-acetylaspartate, Glutamate/Glutamine Levels) as an indicator of brain health measured using non-invasive imaging of magnetic resonance spectroscopy.

The cortisol blood test measures the level of cortisol in the blood. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.

The cortisol saliva test measures the level of cortisol in the saliva. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.

A baseline seizure frequency was recorded for each subject in a diary for eight weeks prior to investigational drug initiation and parents/caregivers documented seizures on a daily basis throughout the trial using a seizure log. For assessing the efficacy of CBD, the investigator counted the change in frequency of seizures per month. The number of seizures within 56 days of the baseline and the number of seizures within 56 days of week 14 were calculated. Higher seizure frequency indicates worse outcome. This outcome is measured as the change in number of seizures per month between the baseline and week 14 time points.