DaTscan for Parkinson's (NCT03019757)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 8 years and 3 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); PET scan (minimally invasive); Blood draw (minimally invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.