Confirmatory Study of the effectiveness of SDS-881 in Participants Aged 50 to 90 years with Suspected Undiagnosed Dementia, No Cognitive Impairment, Diagnosed Dementia, and Diagnosed Mild Cognitive Impairment (MCI).

A Multicenter, Single-Arm, Open-Label Confirmatory Study to Evaluate the effectiveness of SDS-881 in Participants Aged 50 to 90 years with Suspected Undiagnosed Dementia, No Cognitive Impairment, Diagnosed Dementia, and Diagnosed Mild Cognitive Impairment (MCI).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032250114

Enrollment

708

Registered

2025-05-21

Start date

2025-05-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Interventions

The cognitive function tests with MMSE, CDR and LM2, and record of daily conversation for at least 10 minutes by the study intervention will be performed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Participants aged 50 to 90 years, at the time of sigining the informed consent form. -Participants who meet any of the following criteria. - Suspected undiagnosed dementia; those who have not been diagnosed with dementia or MCI in the past and visit the hospital with a primary complaint of cognitive decline. - No Cognitive Impairment; those accompanying outpatients or those who visit the hospital with a primary complaint other than cognitive decline. - Diagnosed dementia; those who have been diagnosed with dementia in the past. - Diagnosed MCI; those who have been diagnosed with MCI in the past. -Male or female.

Exclusion criteria

Exclusion criteria: -Participants who have been diagnosed with severe dementia (CDR score of 3). -Participants who the investigator judges to have difficulty speaking due to hearing loss, dysarthria, aphasia, etc. -Participants with a history of pyschiatric disorder that may affect cognitive function, such as depression, bipolar disorder, schizophrenia spectrum disorder, attention deficit hyperactivity disorder, etc.

Design outcomes

Primary

Measure	Time frame
Judgment results of SDS-881: "cognitive function equivalent to dementia or MCI" or "cognitive function equivalent to healthy individuals"	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026