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Protocol for Development and Validation of a Mild Cognitive Impairment (MCI) Screener in India

Protocol for Development and Validation of a Mild Cognitive Impairment (MCI) Screener India. - Not Applicable

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/103720
Enrollment
500
Registered
2026-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: Z139- Encounter for screening, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Nostalgic Dust Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 55 85 years 2) Able to read, understand, and communicate in English 3) Cognitively healthy adults with no diagnosed cognitive impairment, or individuals with subjective memory or cognitive concerns, or patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) 4) Familiarity with smartphone use, defined as a score of 11 or more on the Digital Access & Technology Use scale 5)Access to a smartphone with internet connectivity

Exclusion criteria

Exclusion criteria: 1) Uncontrolled medical, neurological, or neurodegenerative condition that may contribute to cognitive impairment 2) Serious or unstable systemic illness likely to affect cognitive performance or ability to complete study procedures 3)Moderate to severe depressive symptoms (PHQ-9 score 10 or more) 4)Moderate to severe anxiety symptoms (GAD-7 score 10 or more) 5) Major psychiatric disorder meeting DSM-5 diagnostic criteria

Design outcomes

Primary

MeasureTime frame
Detect Mild Cognitive Impairment (MCI), by measuring its sensitivity and specificity, compared against a clinical diagnosis of MCI supported by ACE-III scoresTimepoint: Baseline

Secondary

MeasureTime frame
Identification of Ivory screener cognitive & voice-based tasks that most effectively differentiate cognitively healthy older adults from individuals with MCI. Timepoint: Baseline;Establishment of optimal Ivory screener cut-off scores for classification of cognitively healthy older adults versus MCI. Timepoint: Baseline;Comparison of diagnostic performance of cognition only voice only & combined cognitive voice models within the Ivory screenerTimepoint: Baseline

Countries

India

Contacts

Public ContactSumiti Saharan

NOSTALGIC DUST PRIVATE LIMITED

sumiti@liveivory.com9560105666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026