UMIN-ICDS Clinical Trial

Public title

Stratified Testing for Risk Identification using Digital and Blood Evaluations in Prodromal Alzheimer's Disease

Acronym

STRIDE-PAD Study

Scientific Title

Stratified Testing for Risk Identification using Digital and Blood Evaluations in Prodromal Alzheimer's Disease

Scientific Title:Acronym

STRIDE-PAD Study

Region

Japan

Condition

Mild cognitive impairment and mild dementia due to Alzheimer's disease

Classification by specialty

Neurology	Geriatrics	Psychiatry
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study tests whether a stepwise (hierarchical) diagnostic pathway that combines a self-administered digital cognitive assessment (MoCA Solo-J) performed in primary care with an Alzheimer's disease blood biomarker (plasma pTau217/Abeta42) reduces the false-positive rate for identifying mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease, compared with the blood biomarker alone. Eight hundred community-dwelling residents aged 50 to 89 years in Beppu City, Oita, Japan undergo XpressO screening at a community health check-up, MoCA Solo-J at their primary care physician's office, and plasma pTau217/Abeta42 measurement. Using specialist assessment including CDR and amyloid PET as the reference standard, the diagnostic performance (accuracy, PPV, NPV, sensitivity, and specificity) of four diagnostic strategies is compared: (A) usual primary care practice, (B) digital cognitive assessment alone, (C) blood biomarker alone, and (D) the hierarchical diagnostic pathway. Secondary objectives are to estimate an appropriate plasma pTau217/Abeta42 cutoff value in a Japanese community-dwelling cohort and to evaluate the utility of MoCA Solo-J in routine primary care.

Basic objectives2

Others

Basic objectives -Others

Observational Study

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1.Performance in identifying MCI and dementia due to Alzheimer's disease: The performance of each comparison group, Groups A-D, in identifying MCI and dementia due to Alzheimer's disease, using a comprehensive assessment by specialists as the reference standard. The performance measures will include accuracy, positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity.
2.Difference in false-positive rates between the hierarchical diagnostic pathway, Group D, and AD blood-based biomarker testing alone, Group C. The reduction in false positives achieved by introducing the hierarchical diagnostic pathway, compared with AD blood-based biomarker (AD BBM) testing alone.

Key secondary outcomes

1. Comparison with assessment by primary care physicians alone
2. Comparison of the results of primary care physicians' questionnaire-based assessments of MCI using a cognitive function checklist with the performance of Solo-J alone, Group B, and Solo-J plus AD BBM, Group D, in identifying MCI and dementia due to Alzheimer's disease.
3. Diagnostic accuracy measures: Evaluation of accuracy, PPV, NPV, sensitivity, and specificity in each comparison group.
4. Characterization of false-negative and false-positive cases and analysis of discordant cases, including the clinical characteristics of cases with discordant Solo-J and BBM results.
5. Validation of the pTau217/Abeta42 cutoff value among XpressO-positive participants: Receiver operating characteristic (ROC) analysis will be performed using data from all 800 participants, including those in the XpressO-negative group, to determine and validate the optimal cutoff value through comparison with AD BBM results. A cutoff value appropriate for the Japanese population will be estimated based on prior validation of the XpressO cutoff value.
6. Proportion of participants in the intermediate group, or gray zone
7. The proportion and outcomes of participants with MoCA Solo-J scores of 21-25.
8. Correlation with DCA scores: Analysis of the correlations between XpressO and Solo-J scores and BBM values.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

All of the following must be met:
(1) Resident of Beppu City, Oita Prefecture, Japan
(2) Aged 50 years or older and under 90 years at the time of consent (either sex)
(3) Physically and mentally healthy
(4) No diagnosis of dementia
(5) Independent in activities of daily living
(6) Able to understand and comply with the study requirements
(7) Clinical Dementia Rating (CDR) of 0 or 0.5

Key exclusion criteria

Any of the following:
(1) Psychiatric disorder, neurodegenerative disease, or drug dependence, or a history thereof, considered to be a cause of cognitive decline other than Alzheimer's disease
(2) Alcohol dependence or a history thereof
(3) Drug dependence or a history thereof
(4) Severe hepatic impairment
(5) Severe renal impairment, including patients on haemodialysis
(6) Participation in a clinical trial or other clinical study within 3 months before enrolment
(7) Blood donation or other blood sampling of 200 mL or more within 1 month, or 400 mL or more within 3 months, before enrolment
(8) Any other condition that, in the judgement of the investigator, makes the person unsuitable as a participant

Target sample size

800

Name of lead principal investigator

1st name	Noriyuki
Middle name
Last name	Kimura

Organization

Oita University Faculty of Medicine

Division name

Department of Neurology

Zip code

879-5593

Address

1-1 Idaigaoka, Hasma, Yufu, Oita, Japan

TEL

097-586-5814

Email

noriyuki@oita-u.ac.jp

Name of contact person

1st name	Noriyuki
Middle name
Last name	Kimura

Organization

Oita University Faculty of Medicine

Division name

Department of Neurology

Zip code

879-5593

Address

1-1 Idaigaoka, Hasma, Yufu, Oita, Japan

TEL

097-586-5814

Homepage URL

Email

noriyuki@oita-u.ac.jp

Institute

Oita University Faculty of Medicine

Institute

Department

Personal name

Organization

Theoria technologies Co., Ltd.
Fujirebio Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The institutional review board of Oita University, Faculty of medicine

Address

1-1 Idaigaoka, Hasma, Yufu, Oita, Japan

Tel

097-586-5157

Email

rinrikenkyu@oita-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

05

Month

08

Day

Date of IRB

2026

Year

06

Month

23

Day

Anticipated trial start date

2026

Year

09

Month

06

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

none

Registered date

2026

Year

10

Month

06

Day

Last modified on

2026

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071848