Subjective Cognitive Decline: SCD
Conditions
Interventions
None listed
Sponsors
Juntendo University Hospital Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i)Persons between 50 to 85 when informed consent is obtained. (ii)A subject who recognizes that cognitive functioning is lower than before, but objective cognitive decline cannot be confirmed by neuropsychological testing at the baseline. (iii)A person who fully understands the study protocol and who provides freely given written informed consent. (iv) A person who has a specific study partner.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYukina Takaoka
A2 Healthcare Corporation Clinical Research Department
Outcome results
None listed