Epidemiological Study of Subjective Cognitive Decline (SCD)

Not Applicable

• Conditions: Subjective Cognitive Decline: SCD

• Registration Number: JPRN-UMIN000033149
• Lead Sponsor: Juntendo University Hospital Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(i)A person who is in the state that may affect impaired cognitive function. (ii)A person who has experienced epileptic seizures in the past five years before screening or who is observed to have a disability in the past five years before screening, and it very likely due to epileptic seizures. (iii)A person who had transient ischemic attacks or strokes in the past 12 months before screening. (iv)A person whose revised version of the Hachinski Ischemic Score is 5 or more during screening. (v)A person with mental disorders or mental symptoms that is considered by the study investigator or the study subinvestigator to have the possibility of interfering with the implementation of the study. (vi)A person who uses a cardiac pacemaker, defibrillator, or ferromagnetic metallic implant, which is considered to be a contraindication to MRI testing. (vii)A person who shows a clinically relevant lesion that supports the diagnosis of dementia in MRI testing during screening. Other than the above, a person with a clinically relevant pathological finding other than dementia. (viii)A person whose laboratory results during screening fall into either of the following: A person whose TSH value exceeds the upper limit of the baseline. A person whose vitamin B12 value in serum is abnormally low. (ix)Other than the above, a person who is judged to be inappropriate as a subject by the principle investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Targeting SCD, the change from the baseline of the Clinical Dementia Rating (CDR) and The Rivermead Behavioural Memory Test (RBMT) will be monitored as indicators for 24 months, and the rate of subjects when transferring to MCI will be examined.

Secondary Outcome Measures

Name	Time	Method
The clinical change (SCD-Q, MBI-C, GDS-15-J, UPSIT) when SCD is transferred to MCI within 24 months will be evaluated, and the background factors that led the transfer to MCI will be examined.