Testing SMIP against a placebo for mild cognitive impairment
Official title: Spatial Memory Training and Cognitive Function
- 2 groups
- One site, in Verdun
- Recruiting
Interventions
- Behavioural therapy
SMIP
Participants will undergo a 3-month-long regimen of 60 minutes spatial memory training sessions held twice a week, consisting of a series of computerized virtual reality tasks.
- Other intervention
No intervention
Control participants will not receive spatial memory intervention training. They will watch documentaries and then complete multiple choice quizzes on its content to ensure they are paying attention. The placebo condition will match the experimental condition in terms of duration and visit frequency.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Douglas Mental Health University Institute
Verdun, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 55 years and above.
- +Primary language is English or French.
- +Individuals having received a diagnosis of Mild Cognitive Impairment (MCI).
Exclusion
- −Self-reported having either of the following:
- −Current post-traumatic stress disorder and/or generalized anxiety disorder; Substance use disorder; Significant heart disease (i.e., stroke occurring during 5 years prior to study assessment or cardiac disease non-stabilized with medication); Severe Depression, or a Geriatric Depression Scale (GDS) score greater than 12; Current insomnia disorder.
- −Current medications for sleep problems, or use of medications that affect sleep.
- −Use of antidepressant and anti-anxiety medication for less than 3 months prior to study entry.
- −Use of analgesics with codeine (or other opioids).
- −Use of antipsychotic medication (past or current).
- −Self-reported colour-blindness.
- −General anesthesia in the past year.
- −Suspected or confirmed traumatic brain injury during the last 24 months.
- −Motion sickness or intolerant to virtual reality tasks.
- −Cholesterol or hypertension medication for less than 3 months or changes expected within the next 9 months.
- −History or presence of neurological or psychiatric disorders (other than MCI) that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → may compromise patient safety or study objectives.
- −Current severe medical conditions (e.g. untreated diabetes, cancer) that in the opinion of the investigator may compromise patient safety or study objectives.
- −For female participants, severe menopausal symptoms, including hot flashes (determined from the Greene climacteric scale - any participants scoring over 15 is excluded).
- −Use of computer games that are designed to help with memory or general cognition.
- −Presence of any medical or psychological condition that, in the opinion of the principal investigator, may compromise the study objectives.
- −Presence of contra-indications for MRI scanning.
- −Having undergone brain surgery or ECT.
- −Current smoker.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives SMIP.
Registry label: A: SMIP
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives No intervention.
Registry label: B: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 55 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 80 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: From study entry to Week 16 in hippocampus SNIPE grading.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in hippocampal atrophy score using SNIPE (Scoring by Non-local Image Patch Estimator) — measured over From study entry to Week 16 in hippocampus SNIPE grading.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07002996 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SMIPBehavioural
Participants will undergo a 3-month-long regimen of 60 minutes spatial memory training sessions held twice a week, consisting of a series of computerized virtual reality tasks.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About No interventionOther
Control participants will not receive spatial memory intervention training. They will watch documentaries and then complete multiple choice quizzes on its content to ensure they are paying attention. The placebo condition will match the experimental condition in terms of duration and visit frequency.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 55 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From study entry to Week 16 in hippocampus SNIPE grading..
The study as a whole is currently expected to finish around 2030-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 80 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Verdun, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Mild cognitive impairment (MCI) is often considered a transitional stage between normal aging and dementia, particularly Alzheimer's disease (AD). Patients with MCI have subjective memory complaints corroborated by standard neuropsychological tests but remain functionally autonomous. One of the first brain regions to show AD pathology is the hippocampus (HPC). Reduction in HPC volume is a strong predictor of AD dementia. Therefore, improvement or restoration of HPC structure and function is thus an attractive target for improvement in memory and AD prevention strategies. In the current study, the investigators propose to examine the effects of a 3-month long spatial memory program on spatial memory and the hippocampus in patients diagnosed with MCI. Neuropsychological tests are also administered before and after the training to assess the effects of the intervention on cognition. In our previous research, the investigators have shown that spatial memory intervention program (SMIP) improves cognition and hippocampal based spatial memory compared to controls.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.