Spatial NavigationBDSC-MCINCT05944601
Exploring to Remediate Behavioral Disturbances of Spatial Cognition
A study testing Virtual and computer-based cognitive remediation training in people with Spatial Navigation, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Navigation
- What is being tested?
- Virtual and computer-based cognitive remediation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age over 65 years;
- education not less than 5 years;
- basic ICT skills measured by the Catholic University devoted software
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring to Remediate Behavioral Disturbances of Spatial Cognition in Community-dwelling Senior Citizens With Mild Cognitive Impairment by Innovative Technological Apparatus.
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.
Read the detailed description
Alzheimer's disease (AD) is characterized by a progressive deterioration of cognitive functions with episodic memory loss and spatial disorientation (SD) as main features. Getting lost in community due to AD is associated with a wide range of negative consequences, such as a strong decrease in patients' quality of life. Episodes of SD in the elderly can increase the possibility of being recovered in a nursing home, caused by a loss of the sense of autonomy as well as an increase in potential injuries and, in the worst cases, even death. Additionally, caregiver burden and increased stress, as well as scarce community resources represent other significant problems related to patients' SD. New technological solutions, such as virtual reality (VR), represent promising means for AD assessment and intervention, especially when they can reveal poor ecological performances. In addition to the advanced age, the ε4 allele of Apolipoprotein-E (APO-E) represents the most important risk factor for AD, providing the opportunity to evaluate subclinical behavioral alterations in individuals with subjective cognitive decline (SCD), and Mild Cognitive Impairment (MCI) due to AD, which represents the prodromic phase of dementia. Deterioration of spatial navigation (SN) abilities is often present early in the course of AD. Therefore, a better understanding the neural mechanisms related to SN impairment in patients at high risk of developing AD can help timely diagnosis and intervention. The present study, adopting a technological apparatus for the detection and the rehabilitation of SN deficits, aims to: (i) investigate the performances obtained on SN tasks in a sample of community-dwelling older adults grouped into three levels (healthy controls, individuals with SCD and patients with MCI due to AD), undergoing virtual (The AppeGame) and naturalistic open-space tests (Detour Navigation Test-modified version); (ii) correct SN deficits by computer-based cognitive remediation sessions and VR sessions; (iii) educate participants at high risk of developing dementia about the opportunity offered by technology in supporting SN in exploring urban circuits.
We will analyze results of the virtual and ecological tasks of SN as a function of age, ApoE genotype and belonging of one the three groups, using a multiple linear regression model. The subgroups of participants at highest risk of developing AD will be administered the aforementioned combined cognitive rehabilitation sessions, with a test/retest analysis. Finally, through an online technological monitoring system, participants will be provided personalized feedbacks via smartphone digital health applications connected to a wearable equipped with sensors, in order to self-manage during their journeys alone in urban environments thanks to the use of threshold algorithms capable of supporting their SN.
- Conditions
- Spatial Navigation
- Being tested
- Virtual and computer-based cognitive remediation training
- Keywords
- spatial navigation, Alzheimer's disease, mild cognitive impairment, subjective cognitive decline, elderly, APOE, assistive technology
- Medical subject headings
- Spatial Navigation, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual and computer-based cognitive remediation trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual and computer-based cognitive remediation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Higher performances in the Corsi learning Suvra-span test
Measured: December 2023-January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial NavigationStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944601
- Sponsor's protocol ID
- 03A203
- Acronym
- BDSC-MCI
- Status last verified
- May 2024
- First submitted
- 6 Jul 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring to Remediate Behavioral Disturbances of Spatial Cognition in Community-dwelling Senior Citizens With Mild Cognitive Impairment by Innovative Technological Apparatus.
- ClinicalTrials.gov ID
- NCT05944601
- Acronym / sponsor ID
- BDSC-MCI / 03A203
- Conditions
- Spatial Navigation
- Keywords
- spatial navigation, Alzheimer's disease, mild cognitive impairment, subjective cognitive decline, elderly, APOE, assistive technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer's disease (AD) is characterized by a progressive deterioration of cognitive functions with episodic memory loss and spatial disorientation (SD) as main features. Getting lost in community due to AD is associated with a wide range of negative consequences, such as a strong decrease in patients' quality of life. Episodes of SD in the elderly can increase the possibility of being recovered in a nursing home, caused by a loss of the sense of autonomy as well as an increase in potential injuries and, in the worst cases, even death. Additionally, caregiver burden and increased stress, as well as scarce community resources represent other significant problems related to patients' SD. New technological solutions, such as virtual reality (VR), represent promising means for AD assessment and intervention, especially when they can reveal poor ecological performances. In addition to the advanced age, the ε4 allele of Apolipoprotein-E (APO-E) represents the most important risk factor for AD, providing the opportunity to evaluate subclinical behavioral alterations in individuals with subjective cognitive decline (SCD), and Mild Cognitive Impairment (MCI) due to AD, which represents the prodromic phase of dementia. Deterioration of spatial navigation (SN) abilities is often present early in the course of AD. Therefore, a better understanding the neural mechanisms related to SN impairment in patients at high risk of developing AD can help timely diagnosis and intervention. The present study, adopting a technological apparatus for the detection and the rehabilitation of SN deficits, aims to: (i) investigate the performances obtained on SN tasks in a sample of community-dwelling older adults grouped into three levels (healthy controls, individuals with SCD and patients with MCI due to AD), undergoing virtual (The AppeGame) and naturalistic open-space tests (Detour Navigation Test-modified version); (ii) correct SN deficits by computer-based cognitive remediation sessions and VR sessions; (iii) educate participants at high risk of developing dementia about the opportunity offered by technology in supporting SN in exploring urban circuits.
We will analyze results of the virtual and ecological tasks of SN as a function of age, ApoE genotype and belonging of one the three groups, using a multiple linear regression model. The subgroups of participants at highest risk of developing AD will be administered the aforementioned combined cognitive rehabilitation sessions, with a test/retest analysis. Finally, through an online technological monitoring system, participants will be provided personalized feedbacks via smartphone digital health applications connected to a wearable equipped with sensors, in order to self-manage during their journeys alone in urban environments thanks to the use of threshold algorithms capable of supporting their SN.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Virtual and computer-based cognitive remediation trainingPatients with Mild Cognitive Impairment with abnormal spinal fluid test for amyloid beta protein. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age over 65 years;
- education not less than 5 years;
- basic ICT skills measured by the Catholic University devoted software
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual and computer-based cognitive remediation trainingAmyloid-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). | Behavioural | patients with MCI due to AD |
Primary outcome
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
Time frame: March-November 2023
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
1 secondary outcome
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
Time frame: December 2023-January 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual and computer-based cognitive remediation training in people with Spatial Navigation, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: March-November 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.