Measure cognitive decline in Parkinsons
- Trial ID
- NCT04997642
- Official Title
- Parkinson's Disease and Movement Disorders Clinical Database
- Goal
- Measure cognitive decline in Parkinsons
- Status
- RECRUITING
- Sponsor
- University of Pennsylvania
- Study Type
- OBSERVATIONAL
- Enrollment
- 250 participants
- Conditions
- Parkinson Disease, Parkinson Disease Dementia, Lewy Body Parkinson Disease, Lewy Body Dementia With Behavioral Disturbance
- Interventions
- neuropsychiatric and cognitive testing questionnaires
Summary For Families
The goal is to build a clinical database to better understand how thinking, memory and neuropsychiatric symptoms change over time in Parkinson's and related Lewy body disorders, so researchers can spot patterns and design better care and trials. Participants complete standardized cognitive tests and neuropsychiatric questionnaires about mood, behavior and daily thinking during routine visits, and those data are collected and tracked over time; this is observational, not a treatment trial. The database plans to enroll about 250 people. Adults 18 and older with a Parkinson's diagnosis who have mild cognitive impairment or dementia and who can complete the assessments are eligible, with no age or disease severity limits beyond the ability to participate.
Locations
- University of Pennsylvania, Philadelphia, Pennsylvania, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying neuropsychiatric and cognitive testing questionnaires. The goal is to build a clinical database to better understand how thinking, memory and neuropsychiatric symptoms change over time in Parkinson's and related Lewy body disorders, so researchers can spot patterns and design better care and trials. Participants complete standardized cognitive tests and neuropsychiatric questionnaires about mood, behavior and daily thinking during routine visits, and those data are collected and tracked over time; this is observational, not a treatment trial. The database plans to enroll about 250 people. Adults 18 and older with a Parkinson's diagnosis who have mild cognitive impairment or dementia and who can complete the assessments are eligible, with no age or disease severity limits beyond the ability to participate.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 10 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.