NCT05711888

Brief Summary

The goal of this study is to observe the outcomes of a semantic recognition task in Alzheimer Disease and discuss what this might add to clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
19mo left

Started Dec 2022

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2027

Expected
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

January 26, 2023

Last Update Submit

September 30, 2024

Conditions

Keywords

Alzheimer DiseaseRecognitionSemanticMemoryFree and Cued Selective Reminding Test

Outcome Measures

Primary Outcomes (1)

  • Semantic Recognition Task

    The number of correct answers will be observed just after the short-term learning procedure and just after the delayed recall procedure among people with positive biomarker compared to those with negative biomarker to Alzheimer Disease.

    1 day

Study Arms (1)

Semantic information in Alzheimer Disease

EXPERIMENTAL

To observe the semantic information processing in early stages of Alzheimer Disease is the main aim of the study. A paper-pencil neuropsychological assessment battery will be used. For memory testing FCSRT (free and cued selective reminding test) will be used. The patients are going to be assessed while in clinical diagnosis routine.

Behavioral: Semantic Recognition Procedure

Interventions

A semantic recognition task is going to be added to administrated FCSRT procedure after immediate and delayed recall phases.

Semantic information in Alzheimer Disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to have biomarker analysis for Alzheimer disease (positive or negative).

You may not qualify if:

  • illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jbid Dursun Uncu

Beşiktaş, Istanbul, 34340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • İ. Hakan Gürvit, Prof. MD.

    Istanbul University

    STUDY DIRECTOR

Central Study Contacts

Jbid Dursun Uncu, Psy. M.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Semantic recognition task outcomes are observed in people diagnosed with Alzheimer's disease with Non-Alzheimer population.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

December 21, 2022

Primary Completion

September 20, 2025

Study Completion (Estimated)

December 26, 2027

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations