Exploring to Remediate Behavioral Disturbances of Spatial Cognition

NCT05944601 | Active Not Recruiting

• 1 other identifier: 03A203
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Spatial navigation (SN) has been reported to be one of the first cognitive domains to be affected in Alzheimer's disease (AD), which occurs as a result of progressive neuropathology involving specific brain areas. Moreover, the epsilon 4 isoform of Apolipoprotein-E (APOE-ε4) has been associated with both sporadic and familial late-onset AD and patients with Mild Cognitive Impairment (MCI) due to AD are more likely to progressively deteriorate. It will be investigated (i) whether amyloid-positive MCI patients and APOE-ε4 carriers show subtle changes of SN prior to the overt symptoms of AD disorientation, both in virtual and in naturalistic open-space tasks, and (ii) the effect of a combined treatment of computer-based and virtual reality tasks in those presenting such an impairment. Finally, (iii) threshold algorithms based on physiological parameters and gait analysis will be set up to support senior citizens at increased risk in maintaining their ability to independently navigate urban environments. Different types of navigational guidance will be examined on a sample of 76 older adults by the AppleGame, and the Detour Navigation Test-modified version. It is expected that patients with MCI due to AD and APOE-ε4 carriers show reduced SN performances than individuals with subjective cognitive impairment and healthy controls in the experimental tasks, with potential improvements after cognitive rehabilitation. Altered SN performances of individuals at increased risk to develop AD may inform future advanced technological applications in providing valuable information on threshold algorithms based on physiological parameters and gait analysis during elders' traveling to unfamiliar locations.

Conditions

Spatial Navigation

Keywords

spatial navigation; Alzheimer's disease; mild cognitive impairment; subjective cognitive decline; elderly; APOE; assistive technology

Outcome Measures

Primary Outcomes (1)

• Detecting drop errors (DEs) and composite disorientation score (CDS) in individuals at increased risk to develop AD in virtual and naturalistic spatial navigation tasks, respectively

  Lower performances in virtual navigation tasks (higher DEs) and in naturalistic navigation (CDS\>1) in patients with MCI due to AD and in APOE-e4 carriers than healthy controls and individuals with subjective cognitive decline

  March-November 2023

Secondary Outcomes (1)

• Improving spatial memory after a combined cognitive training (virtual reality and computer-based cognitive remediation) in a subgroup of patients with MCI due to AD and APOE-e4 carriers

  December 2023-January 2024

Other Outcomes (1)

• To educate a dyad (subject and caregiver) about the usefulness of a portable assistive technology for spatial navigation in community settings

  January 2023-February 2024

Study Arms (3)

Healthy controls

NO INTERVENTION

Elderly people without cognitive impairment or subjective cognitive decline.

Subjective cognitive decline

NO INTERVENTION

Individuals presenting cognitive complains that are not confirmed by neuropsychological testing.

patients with MCI due to AD

EXPERIMENTAL

Patients with Mild Cognitive Impairment with abnormal spinal fluid test for amyloid beta protein.

Behavioral: Virtual and computer-based cognitive remediation training

Interventions

Virtual and computer-based cognitive remediation training BEHAVIORAL

Amyloid-positive MCI patients, and individuals carrying the ApoE- ε4 allele will undergo a combined intervention of computer-based sessions of a spatial memory task by the Erica software (Giunti, Florence, Italy) and VR navigation sessions by the NeuroVirtual 3D software (Serino et al., 2010), in order to improve spatial memory for landmarks location and mental frame syncing for supporting spatial scenarios, respectively. The intervention will last one month for a total of 12 sessions (3 days a week, 50 minutes per session).

patients with MCI due to AD

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age over 65 years;
• education not less than 5 years;
• basic ICT skills measured by the Catholic University devoted software

You may not qualify if:

• presence of visual, hearing or motor impairment significantly interfering with spatial navigation tasks;
• neurological/psychiatric disease or other medical conditions preventing spatial navigation;
• history of alcohol or drugs addiction;
• intake of psychotropic drugs;
• presence of dementia.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, Lombardy, 20149, Italy

Location

MeSH Terms

Conditions

Spatial Navigation; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: March 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: June 30, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

IT (1)