NCT07002996

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2025Dec 2030

First Submitted

Initial submission to the registry

May 7, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5.3 years

First QC Date

May 7, 2025

Last Update Submit

July 18, 2025

Conditions

Keywords

MemorySpatial MemoryHippocampusCognitive TrainingCognitive DeclineAging

Outcome Measures

Primary Outcomes (1)

  • Change in hippocampal atrophy score using SNIPE (Scoring by Non-local Image Patch Estimator)

    Hippocampal atrophy will be assessed by applying the SNIPE algorithm to T1-weighted structural MRI scans. The SNIPE score quantifies similarity of hippocampal image patches to those found in Alzheimer's disease (AD) patients and cognitively healthy controls, providing a continuous score ranging from -1 (AD-like) to +1 (control-like). Change in SNIPE score from baseline to post-treatment will be used to evaluate the effect of the intervention on neurodegeneration.

    From study entry to Week 16 in hippocampus SNIPE grading.

Secondary Outcomes (37)

  • Hippocampal volume.

    From study entry to weeks 16 and 41.

  • Change in hippocampal atrophy score using SNIPE (Scoring by Non-local Image Patch Estimator) at 41 weeks post-study entry.

    From study entry to Week 41.

  • Changes in spatial memory performance.

    From study entry to weeks 15 and 40.

  • Changes in spatial memory performance: radial maze task.

    From study entry to weeks 15 and 40.

  • Changes in spatial memory performance: Paired arms radial maze task.

    From study entry to weeks 15 and 40.

  • +32 more secondary outcomes

Study Arms (2)

SMIP

EXPERIMENTAL

Spatial Memory Intervention Program

Behavioral: SMIP

Control

PLACEBO COMPARATOR

The control group will receive no intervention between baseline and follow-up.

Other: No intervention

Interventions

SMIPBEHAVIORAL

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.

SMIP

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.

Control

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years and above.
  • Primary language is English or French.
  • Individuals having received a diagnosis of Mild Cognitive Impairment (MCI).

You may not qualify if:

  • 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).
  • Having undergone brain surgery or ECT.
  • Self-reported colour-blindness.
  • General anesthesia in the past year.
  • Current smoker.
  • 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 investigator 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Verdun, Quebec, H4G 3E8, Canada

RECRUITING

Related Publications (3)

  • Bohbot VD, Iaria G, Petrides M. Hippocampal function and spatial memory: evidence from functional neuroimaging in healthy participants and performance of patients with medial temporal lobe resections. Neuropsychology. 2004 Jul;18(3):418-25. doi: 10.1037/0894-4105.18.3.418.

    PMID: 15291720BACKGROUND
  • Bohbot VD, Lerch J, Thorndycraft B, Iaria G, Zijdenbos AP. Gray matter differences correlate with spontaneous strategies in a human virtual navigation task. J Neurosci. 2007 Sep 19;27(38):10078-83. doi: 10.1523/JNEUROSCI.1763-07.2007.

    PMID: 17881514BACKGROUND
  • Iaria G, Petrides M, Dagher A, Pike B, Bohbot VD. Cognitive strategies dependent on the hippocampus and caudate nucleus in human navigation: variability and change with practice. J Neurosci. 2003 Jul 2;23(13):5945-52. doi: 10.1523/JNEUROSCI.23-13-05945.2003.

    PMID: 12843299BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Véronique Bohbot, Ph.D.

    Douglas Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 7, 2025

First Posted

June 4, 2025

Study Start

June 15, 2025

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations