Dementia Clinical Trial
Official title:
DaTSCAN Imaging in Aging and Neurodegenerative Disease
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD), mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Diagnosis of one of the syndromes of interest using established criteria - Age 40-90 inclusive - MMSE score above 10 - No active medical disorder that could preclude participation - Stable medication regimen over previous four weeks - Absence of certain medications that could significantly impact the DaTscan findings - For those with dementia, caregiver that is with the patient at least 4 hours/day for at least 5 days per week - For those with dementia, or severe parkinsonism, patient and caregiver willing and able to participate in all study-related procedures - Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf. Exclusion Criteria: - Does not fulfill criteria for any of the desired diagnoses - Age <40 or >90 - Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative - Women who are pregnant or are breast-feeding an infant - MMSE score <10 - Active medical disorder that could preclude participation in this protocol - Hypersensitivity to the radioligand, cocaine, or iodine (including seafood allergy) - Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease - Renal or liver disease viewed by the physician to be too severe to warrant DaTscan infusion/imaging - History of significant alcohol or drug abuse - Any other medical disorder considered by the study physicians as inappropriate for this protocol - Patient or caregiver unwilling or unable to participate in all study-related procedures - Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week - Patient or caregiver unwilling or unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Arnaldi D, Chincarini A, Hu MT, Sonka K, Boeve B, Miyamoto T, Puligheddu M, De Cock VC, Terzaghi M, Plazzi G, Tachibana N, Morbelli S, Rolinski M, Dusek P, Lowe V, Miyamoto M, Figorilli M, Verbizier D, Bossert I, Antelmi E, Meli R, Barber TR, Trnka J, Miy — View Citation
Arnaldi D, Mattioli P, Raffa S, Pardini M, Massa F, Iranzo A, Perissinotti A, Ninerola-Baizan A, Gaig C, Serradell M, Munoz-Lopetegi A, Maya G, Liguori C, Fernandes M, Placidi F, Chiaravalloti A, Sonka K, Dusek P, Zogala D, Trnka J, Boeve BF, Miyagawa T, Lowe VJ, Miyamoto T, Miyamoto M, Puligheddu M, Figorilli M, Serra A, Hu MT, Klein JC, Bes F, Kunz D, Cochen De Cock V, de Verbizier D, Plazzi G, Antelmi E, Terzaghi M, Bossert I, Kulcsarova K, Martino A, Giuliani A, Pagani M, Nobili F, Morbelli S; International REM Sleep Behavior Disorder Study Group. Presynaptic Dopaminergic Imaging Characterizes Patients with REM Sleep Behavior Disorder Due to Synucleinopathy. Ann Neurol. 2024 Mar 11. doi: 10.1002/ana.26902. Online ahead of print. — View Citation
Chen Q, Lowe VJ, Boeve BF, Przybelski SA, Miyagawa T, Senjem ML, Jack CR Jr, Lesnick TG, Kremers WK, Fields JA, Min HK, Schwarz CG, Gunter JL, Graff-Radford J, Savica R, Knopman DS, Jones D, Ferman TJ, Graff-Radford NR, Petersen RC, Kantarci K. beta-Amylo — View Citation
Diaz-Galvan P, Miyagawa T, Przybelski SA, Lesnick TG, Senjem ML, Jack CR Jr, Forsberg LK, Min HK, St Louis EK, Savica R, Fields JA, Benarroch EE, Lowe V, Petersen RC, Boeve BF, Kantarci K. Brain glucose metabolism and nigrostriatal degeneration in isolate — View Citation
Jung Y, Jordan LG 3rd, Lowe VJ, Kantarci K, Parisi JE, Dickson DW, Murray ME, Reichard RR, Ferman TJ, Jones DT, Graff-Radford J, Savica R, Machulda MM, Fields JA, Allen LA, Drubach DA, St Louis EK, Silber MH, Jack CR Jr, Knopman DS, Petersen RC, Boeve BF. — View Citation
Maltais DD, Jordan LG, Min HK, Miyagawa T, Przybelski SA, Lesnick TG, Reichard RR, Dickson DW, Murray ME, Kantarci K, Boeve BF, Lowe VJ. Confirmation of 123I-FP-CIT SPECT Quantification Methods in Dementia with Lewy Bodies and Other Neurodegenerative Diso — View Citation
Miyagawa T, Przybelski SA, Maltais D, Min HK, Jordan L, Lesnick TG, Chen Q, Graff-Radford J, Jones D, Savica R, Knopman D, Petersen R, Kremers WK, Forsberg LK, Fields JA, Ferman TJ, Allen L, Parisi J, Reichard RR, Murray M, Dickson D, Boeve BF, Kantarci K — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlate the DaTscan findings with clinical diagnosis | The primary endpoint is to correlate the DaTscan findings with clinical diagnosis | Participants will be followed to 1-3 days after scan. | |
Secondary | Safety of DaTscan imaging | The primary safety/tolerability endpoint relates to side effects associated with DaTscan imaging | Participants will be followed for 1-3 days after scan. |
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