Mild Cognitive Impairment (MCI) / Mild Alzheimer Disease · Observational Study

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

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed observational feasibility study registered to evaluate a mobile cognitive assessment application with dynamic difficulty adjustment in mild cognitive impairment and Alzheimer's disease populations. The registry record documents the study design and planned outcomes but does not report results, and thus provides no evidence of clinical or functional benefit.

What was studied

Observational. Mild Cognitive Impairment (MCI), Mild Alzheimer Disease; age from 50 Years; to 90 Years; accepts healthy volunteers. Intervention: PwMCI/AD; HC. Compared with: Comparison between people with MCI/mild AD and healthy controls; no active comparator arm.. n = 32. 1 site: United States.

Key findings

Safety

No information on safety, adverse events, or dropout rates provided.

Who this may help

Pending results publication. Clinicians cannot assess the validity or utility of this mobile cognitive monitoring tool based on this registry record alone.

Plain-language summary

Observational feasibility study with completed enrollment (n=32) assessing application functionality and usability; no results posted in this registry record, limiting evidentiary weight.

Study design

As stated by the source record.

MethodsCase Control model. Prospective time perspective. Primary outcome measures: Number of test iterations until stable difficulty level is reached (assessed at During the 6-week study period.); Distribution of participants across assessment levels at steady-state difficulty (assessed at During the 6-week study period)

DesignObservational

PopulationMild Cognitive Impairment (MCI), Mild Alzheimer Disease; age from 50 Years; to 90 Years; accepts healthy volunteers

Sample size32

InterventionPwMCI/AD; HC

ComparatorComparison between people with MCI/mild AD and healthy controls; no active comparator arm.

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size32

Study duration6 weeks

Primary outcome measure 1Number of test iterations until stable difficulty level is reached

Primary outcome measure 2Distribution of participants across assessment levels at steady-state difficulty

Clinical bottom line

Pending results publication. Clinicians cannot assess the validity or utility of this mobile cognitive monitoring tool based on this registry record alone.

Caveats

No results posted in this registry record; outcomes are planned, not reported.
No comparator arm or control condition described beyond inclusion of healthy controls.
Observational design limits causal inference about application performance.
No information on safety, adverse events, or dropout rates provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design without control arm or randomization; feasibility-focused.

Directness

moderate

Directly tests mobile application performance in target populations (MCI/mild AD and healthy controls).

Consistency

insufficient

No comparative results reported; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias safeguards.

Sample adequacy

limited

Small sample (n=32 total) across two groups; adequate for feasibility, limited for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07174869). This is a study registration, not published results. Lead sponsor: Indivi AG. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 32 participants (ACTUAL). Conditions: Mild Cognitive Impairment (MCI), Mild Alzheimer Disease. Primary outcome measures: Number of test iterations until stable difficulty level is reached , During the 6-week study period.; Distribution of participants across assessment levels at steady-state difficulty , During the 6-week study period. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07174869Mild Cognitive Impairment (MCI)IndiviMild Alzheimer Disease