NCT07163039

Brief Summary

This randomized controlled clinical trial aims to evaluate the effectiveness of dual-task training on cognitive functions in patients with Alzheimer's disease. Participants will be randomly assigned to either a dual-task training group or a conventional exercise group. The intervention will last 8 weeks, with three supervised sessions per week. Cognitive performance, mobility, balance, and quality of life will be assessed before and after the intervention.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable alzheimer-disease

Status
not yet 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

First Submitted

Initial submission to the registry

August 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

August 21, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

AlzheimerDual-Task Training

Outcome Measures

Primary Outcomes (5)

  • d2 Test of Attention

    A widely used neuropsychological test evaluating visual attention and processing speed. Participants are asked to quickly and accurately mark target symbols (e.g., the letter "d" with two dashes) among distractors on a sheet consisting of similar letters and symbols.

    From enrollment to the end of treatment at 8 weeks

  • Trail Making Test Part A (TMT-A)

    Assesses visual attention, processing speed, and psychological flexibility. The participant is required to connect numbered circles from 1 to 25 in order as quickly as possible.

    From enrollment to the end of treatment at 8 weeks

  • Stroop Test

    Stroop Test: Evaluates executive functions and attentional control. The participant must state the ink color of a word rather than reading the written word itself (e.g., the word "Blue" written in red ink should be answered as "red")

    From enrollment to the end of treatment at 8 weeks

  • Trail Making Test Part B (TMT-B):

    Trail Making Test Part B (TMT-B): Used to assess executive functions, cognitive flexibility, and attention. The participant alternates between numbers and letters in sequence (1-A-2-B-3-C…)

    From enrollment to the end of treatment at 8 weeks

  • Montreal Cognitive Assessment (MoCA)

    Montreal Cognitive Assessment (MoCA): Evaluates memory, attention, executive functions, and visuospatial skills. It is a standard and validated tool for monitoring cognitive status and comparing pre- and post-intervention performance in Alzheimer's patients

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (13)

  • Symbol Digit Modalities Test (SDMT)

    From enrollment to the end of treatment at 8 weeks

  • Functional Near-Infrared Spectroscopy (fNIRS)

    From enrollment to the end of treatment at 8 weeks

  • Disability Assessment for Dementia (DAD)

    From enrollment to the end of treatment at 8 weeks

  • Dual Task Protocol

    From enrollment to the end of treatment at 8 weeks

  • Performance Measures: Walking speed

    From enrollment to the end of treatment at 8 weeks

  • +8 more secondary outcomes

Study Arms (2)

Dual-task motor-cognitive training

EXPERIMENTAL

Participants assigned to this group will undergo dual-task motor-cognitive training, which combines physical exercises with simultaneous cognitive tasks. Sessions will last 45-60 minutes, three times per week, for 8 weeks. Exercises will include gait and balance activities performed while engaging in cognitive tasks such as arithmetic, memory recall, or word association.

Other: Dual-Task Motor-Cognitive Training

Conventional Exercise Training

ACTIVE COMPARATOR

Participants in this group will receive a conventional exercise program focusing on strength, flexibility, and balance without a cognitive component. Sessions will last 45-60 minutes, three times per week, for 8 weeks, and will be supervised by a physiotherapist.

Other: Conventional Exercise Training

Interventions

Participants assigned to this group will undergo dual-task motor-cognitive training, which combines physical exercises with simultaneous cognitive tasks. Sessions will last 45-60 minutes, three times per week, for 8 weeks. Exercises will include gait and balance activities performed while engaging in cognitive tasks such as arithmetic, memory recall, or word association.

Dual-task motor-cognitive training

Participants in this group will receive a conventional exercise program focusing on strength, flexibility, and balance without a cognitive component. Sessions will last 45-60 minutes, three times per week, for 8 weeks, and will be supervised by a physiotherapist.

Conventional Exercise Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Diagnosed with mild-stage Alzheimer's disease (According to DSM-5 or NINCDS-ADRDA criteria)
  • MoCA score between 10-25 (Indicating sufficient cognitive capacity for dual-task training)
  • Ability to walk independently or with minimal assistance
  • Adequate hearing and vision to enable communication
  • Physical and mental capacity to participate in the dual-task training protocol
  • Provision of written informed consent (signed informed consent form)

You may not qualify if:

  • Diagnosis of advanced-stage Alzheimer's disease (MoCA \< 10)
  • Presence of additional neurological disorders affecting the motor system (e.g. Parkinson's disease, stroke, multiple sclerosis)
  • Severe hearing or vision impairment (inability to respond to visual or auditory stimuli)
  • History of psychiatric disorders (e.g., major depression, schizophrenia)
  • Orthopedic or cardiopulmonary conditions that would prevent participation in dual-task training
  • Participation in another cognitive or physical rehabilitation program within the last 3 months
  • Individuals with unstable cognitive status due to recent medication changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sümeyye AKÇAY, PhD

    Fenerbahçe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu AKKURT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 9, 2025

Study Start

September 1, 2025

Primary Completion

October 1, 2025

Study Completion

May 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share