Mild Cognitive ImpairmentANTagingNCT05768620
Active Navigation Training
A study testing CAVE and TAU in people with Mild Cognitive Impairment and Spatial Navigation, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Spatial Navigation
- What is being tested?
- CAVE and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2020to 1 Jul 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of mild cognitive impairment
- absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
- age ≥ 60
Who cannot join
- the presence of acute stroke/transient ischemic attack;
- the presence of other concomitants severe neurological/psychiatric diseases;
- history of traumatic brain injury with loss of consciousness;
- physical/functional deficits that could affect the use of immersive virtual reality;
- severe visual deficiency;
- the presence of recurrent vertigo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging
Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.
- Conditions
- Mild Cognitive Impairment, Spatial Navigation
- Being tested
- CAVE, TAU
- Keywords
- virtual reality
- Medical subject headings
- Cognitive Dysfunction, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVEOther
The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes
TAUOther
This is the usual care used to train visuospatial processes
| Study group | Role | What they receive |
|---|---|---|
| CAVE | Experimental | 10 immersive virtual reality sessions to train spatial memory Receives: Other: CAVE |
| TAU | Active comparator | 10 paper and pencil sessions to train spatial memory Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corsi supra-span test
Scores range from 0 to 29.16, higher scores indicate better visuospatial learning
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Change in Manikin Test
Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary outcomes (5)
Trail-making test part A and B
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Raccontino (6 Dicembre) (immediate-delayed-forgetting)
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Mini-mental state examination
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Digit span forward
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Corsi Block Tapping
Measured: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Apr 2020
- Primary completion1 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Proof-of-concept trial
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT05768620
- Sponsor's protocol ID
- 39M801
- Acronym
- ANTaging
- Status last verified
- Nov 2023
- First submitted
- 22 Feb 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging
- ClinicalTrials.gov ID
- NCT05768620
- Acronym / sponsor ID
- ANTaging / 39M801
- Conditions
- Mild Cognitive Impairment, Spatial Navigation
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 14 Mar 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.
Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Proof-of-concept trial
| Arm | Type | Receives |
|---|---|---|
| CAVE | Experimental | Other: CAVE10 immersive virtual reality sessions to train spatial memory |
| TAU | Active comparator | Other: TAU10 paper and pencil sessions to train spatial memory |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of mild cognitive impairment
- absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
- age ≥ 60
Key exclusion criteria (6 listed)
- the presence of acute stroke/transient ischemic attack;
- the presence of other concomitants severe neurological/psychiatric diseases;
- history of traumatic brain injury with loss of consciousness;
- physical/functional deficits that could affect the use of immersive virtual reality;
- severe visual deficiency;
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 |
|---|---|---|
| CAVEThe training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes | Other | CAVE |
| TAUThis is the usual care used to train visuospatial processes | Other | TAU |
Primary outcome
Change in Corsi supra-span test
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Scores range from 0 to 29.16, higher scores indicate better visuospatial learning
Change in Manikin Test
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation
5 secondary outcomes
Trail-making test part A and B
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Raccontino (6 Dicembre) (immediate-delayed-forgetting)
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Mini-mental state examination
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Digit span forward
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Corsi Block Tapping
Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
Related trials for Mild Cognitive Impairment
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
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 CAVE and TAU in people with Mild Cognitive Impairment and 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 6 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: finished, as of the sponsor's last update on 27 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Corsi supra-span test (time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up). The study lists 2 primary outcomes in all. 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 27 Nov 2023.