Differentiate dementias using brain imaging
- Trial ID
- NCT03019757
- Official Title
- Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- Goal
- Differentiate dementias using brain imaging
- Status
- RECRUITING
- Sponsor
- Douglas Scharre
- Study Type
- OBSERVATIONAL
- Enrollment
- 76 participants
- Conditions
- Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease
- Interventions
- DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, Clinical Assessment
Summary For Families
The trial aims to help doctors tell Alzheimer’s disease, Lewy body dementia, and Parkinson’s disease apart, because they can look similar but have different causes and treatments. It combines brain scans and tests to find distinct patterns, using DaTscan to measure dopamine transporter loss that points to Parkinsonian syndromes, F18-AV-45 amyloid PET to detect Alzheimer plaques, FDG-PET to map abnormal brain metabolism, APOE genotyping for Alzheimer risk, overnight polysomnography to detect REM sleep behavior disorder common in Lewy body disease, and detailed clinical and cognitive exams. Adults 18 and older who meet standard clinical criteria for one of these diagnoses, have an MMSE of 10 or higher, are on stable cognitive or psychoactive medications for at least four weeks, and have a study partner in regular contact are eligible. People with other medical causes of dementia, severe kidney impairment, pregnancy, less than 12 years of education, non,English first language, or prior exposure to an amyloid-targeting drug (unless only placebo) are excluded.
Locations
- The Ohio State University, Columbus, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DaTscan. The trial aims to help doctors tell Alzheimer’s disease, Lewy body dementia, and Parkinson’s disease apart, because they can look similar but have different causes and treatments. It combines brain scans and tests to find distinct patterns, using DaTscan to measure dopamine transporter loss that points to Parkinsonian syndromes, F18-AV-45 amyloid PET to detect Alzheimer plaques, FDG-PET to map abnormal brain metabolism, APOE genotyping for Alzheimer risk, overnight polysomnography to detect REM sleep behavior disorder common in Lewy body disease, and detailed clinical and cognitive exams. Adults 18 and older who meet standard clinical criteria for one of these diagnoses, have an MMSE of 10 or higher, are on stable cognitive or psychoactive medications for at least four weeks, and have a study partner in regular contact are eligible. People with other medical causes of dementia, severe kidney impairment, pregnancy, less than 12 years of education, non,English first language, or prior exposure to an amyloid-targeting drug (unless only placebo) are excluded.
- 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 8 years and 3 months.
- 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.