A Study To Assess The Feasibility Of Indivi Mobile Applic... | NCT07174869

Studies
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population

NCT07174869

Sponsor

Indivi AG

Status

Recruiting

Last Update Posted

Sep 16, 2025Actual

Enrollment

55Estimated

Phase

Not provided

Conditions

Mild Cognitive Impairment (MCI)
Mild Alzheimer Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Sep 9, 2025

First Submission Date that Met QC Criteria

Sep 9, 2025

First Posted Date

Sep 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user.

The main questions it aims to answer are:

Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC?
Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC?

Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups.

Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PwMCI/AD		Persons with Mild Cognitive Impairment or mild Alzheimer's Disease
HC		Healthy Controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of test iterations until stable difficulty level is reached	Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.	During the 6-week study period.
Distribution of participants across assessment levels at steady-state difficulty	Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.	During the 6-week study period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is part of BU-ADRC cohort.
Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.
Participant is between 50 and 90 years old, included.
Participant is able to use a smartphone.
Participant has sufficient knowledge of the English language.
Participant is able to and has an intention to follow the study procedures.
Informed Consent as documented by signature.

Exclusion Criteria:

Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
Participant has a history of stroke or seizures within the last 24 months.
Participant has a Geriatric Depression Scale (GDS) score ≥8.
Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
Known or suspected non-compliance.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Boston University Alzheimer's Disease Research Center (BU ADRC)

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Boston University School of Medicine	Recruiting	Boston	Massachusetts	02118	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders