Florbetapir diagnostic impact study

Not Applicable

• Conditions: Alzheimer's, cognitive impairment

• Registration Number: JPRN-jRCTs031180446
• Lead Sponsor: Okita Kyoji

Brief Summary

The result suggests that amyloid PET scan has a significant impact on making diagnosis and setting clinical plans. Thus, amyloid PET scan may help making clinical practice more sufficient.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2021-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 119

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified