Alzheimer's, cognitive impairment
Conditions
Interventions
Sponsors
Okita Kyoji
Matsuda Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1: Patients with cognitive impairment in whom Alzheimer's disease is suspected (1). 1. In reference to each diagnostic criterion, the following diseases/states are suspected: 1)Mild cognitive impairment 2)Alzheimer's disease 3)Dementia with Lewy bodies 4)Vascular dementia 5)Behavioral variant of frontotemporal dementia 6)Primary progressive aphasia 7)Semantic dementia 8)Depression 9)Idiopathic normal pressure hydrocephalus 10)Progressive supranuclear palsy 11)Corticobasal degeneration 12)Epilepsy 13)Others (1: The diagnostic confidence for Alzheimer's disease as the cause of the cognitive impairment falls within the range of 15%-85% according to the physician in charge) 2. Patients having the ability to provide informed consent. When it is difficult to obtain it from the patient, consent is provided by the proxies. 3. Prior head MRI scan within 90 days as a clinical routine Cohort 2: Healthy volunteers with normal cognitive function 1)Of Japanese origin, aged between 35 and 50 years old (both sexes are allowed) 2)With a score of 29 or more in the mini-mental state examination (MMSE). Subjects are judged to have normal cognitive function according to their medical history and neurocognitive test battery at screening. 3)Who provided informed consent
Exclusion criteria
Exclusion criteria: Cohort 1: 1. Prior history of amyloid PET scan in other clinical studies or trials 2. Severe dementia with a score of 19 points or less in the MMSE 3. Typical symptoms and course of the disease, with a clear clinical diagnosis of one of the following: 1)Alzheimer's disease 2)Dementia with Lewy bodies 3)Vascular dementia 4)Behavioral variant of frontotemporal dementia 5)Primary progressive aphasia 6)Semantic dementia 7)Depression 8)Idiopathic normal pressure hydrocephalus 9)Progressive supranuclear palsy 10)Corticobasal degeneration 4. Asymptomatic 5. No objective cognitive dysfunction 6. Person judged to be inappropriate to perform amyloid PET examination by investigator in charge Cohort 2: 1. Pregnant women and lactating mothers 2. Who has a cardiac pacemaker, metals in the body, or a tattoo 3. Who has claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of change in diagnosis before and after amyloid PET in amyloid-negative cases | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) In patients with cognitive impairment in whom Alzheimer's disease is suspected: Ratio of change in diagnosis before and after amyloid PET in amyloid-positive cases Change in category (when categorized as AD and non-AD for each diagnosis) before and after amyloid PET Change in diagnostic confidence before and after amyloid PET in each case Ratio of change in the care plan before and after amyloid PET in amyloid-negative and in amyloid-positive cases Summary statistic of the standardized uptake value ratio (SUVR) and mean cortical (mc) SUVR for amyloid-positive and amyloid-negative cases and for each diagnosis after amyloid PET 2) Summary statistic of the SUVR and mcSUVR in cognitive healthy subjects 3) Consistency in images regarding scanning start time (40 min vs 50 min after injection) 4) Exploratory analysis for specific regions with amyloid plaque deposits | — |
Contacts
Public ContactKyoji Okita
National Center of Neurology and Psychiatry
Outcome results
None listed