NCT03532113

Brief Summary

Formal education and cognitively stimulating hobbies and profession have a protective effect against age-related cognitive decline and Alzheimer's disease. It is therefore possible that providing cognitively stimulating interventions at a later age increases neuroplasticity and brain resilience. Processes of updating and inhibition are both impaired by aging. Several studies have shown that updating can be improved but very few studies targeted inhibition in spite of the fact that it is impaired in older adults. The aim of this study is to assess the effect of cognitive interventions that will target either of these two components. The investigators will examine the effect on behavior, brain measures and transfer tasks. The investigators will also assess whether the efficacy varies as a function of personal variables such as prior cognitive profile, reserve proxies, genetic polymorphisms and brain markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 19, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

April 18, 2018

Last Update Submit

January 22, 2020

Conditions

Keywords

Cognitive interventionCognitive trainingAgingWorking memoryCognitive reserveBrain imagingBrain plasticityPolymorphismsTransferInhibitionUpdating

Outcome Measures

Primary Outcomes (2)

  • Changes on the updating composite measure (Proximal outcome).

    An updating composite score will be computed by averaging z-scores from the Keep track task and the Running span task.

    within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  • Changes on the inhibition composite measure (Proximal outcome).

    An inhibition composite score will be computed by averaging z-scores from the Anti-saccade and the Victoria Stroop Test.

    within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

Secondary Outcomes (7)

  • Transfer to complex working memory measure: the Alpha-span task (Distal outcome).

    within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  • Transfer to complex working memory measure: the Reading span task (Distal outcome).

    within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  • Transfer to complex working memory measure: the virtual car ride task (Distal outcome).

    within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  • Brain structure: Regional gray matter volumes in Prefrontal and lateral temporal cortices, Basal ganglia and Hippocampi.

    within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  • Brain structure: Cortical thickness in Prefrontal regions and lateral temporal cortices.

    within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  • +2 more secondary outcomes

Other Outcomes (8)

  • Effect of moderators: Polymorphisms.

    3rd week after intervention starts (after the 6th training session)

  • Effect of moderators: Cognitive reserve proxies.

    within the 2 weeks before intervention starts

  • Effect of moderators: Intracranial volume.

    within the 2 weeks before intervention starts

  • +5 more other outcomes

Study Arms (3)

Updating

EXPERIMENTAL

The Updating intervention aims to improve the ability to monitor and quickly add or delete of content of working memory.

Behavioral: Updating

Inhibition

EXPERIMENTAL

The Inhibition intervention aims to improve the ability to supersede responses that are prepotent or automatic for a given situation.

Behavioral: Inhibition

General Knowledge

ACTIVE COMPARATOR

The General knowledge intervention allows the learning of information on various topics. It does not involve attentional control but semantic knowledge.

Behavioral: General knowledge

Interventions

UpdatingBEHAVIORAL

Updating is trained across 12 sessions using N-back-type exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of the stimuli (numbers vs. symbols) is changed halfway in each session.

Updating
InhibitionBEHAVIORAL

Inhibition is trained across 12 sessions with Stroop-like exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of stimuli (letters vs. numbers) is changed halfway in each session.

Inhibition

General Knowledge is trained across 12 sessions. Participants complete four-choice questions relating to general knowledge and vocabulary and are provided with the correct answer and a short explanation. Questions are displayed one by one on a computer screen with a maximum of 20 seconds per question. Each session lasts 30 minutes and includes 2 blocks of 40 new questions each (about 220 seconds per block). Questions with wrong answers are displayed again at the end of each block.

General Knowledge

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • French-speaking
  • Right-handed
  • Sufficient visual and auditory acuity to undergo neuropsychological tests and to do the interventions.
  • Sufficient delayed recall score above the education-adjusted cut-offs (≥9 for 16+ years of education; ≥5 for 8-15 years of education; ≥3 for 0-7 years of education) at the Logical Memory test (Wechsler Memory Scale, maximum score 25).

You may not qualify if:

  • Answer 'Yes' to the two following questions: "Do you feel like your memory is becoming worse?" "Does this worry you?" (to exclude subjective cognitive decline).
  • The presence of a disease or injury of the central nervous system: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, subdural hematoma (past or current), subarachnoid haemorrhage (past or current), primary cerebral tumour or cerebral metastases, epilepsy (current), dementia or another neurodegenerative disease, and other rarer brain illnesses.
  • Symptomatic stroke within the previous year.
  • Alcoholism or substance abuse
  • History of intracranial surgery.
  • Major surgery within last 2 months.
  • General anesthesia in the past 6 months.
  • Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
  • Major depression or anxiety.
  • Schizophrenia or other major psychiatric disorder (e.g., bipolar disorder).
  • Individuals where French is not sufficiently proficient for clinical assessment and neuropsychological testing.
  • Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
  • Plans on moving outside the province within the next 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W4, Canada

Location

Related Publications (3)

  • Verty LV, Mellah S, Maltezos S, Boujut A, Lussier M, Bherer L, Belleville S. Youth-like brain activation linked with greater cognitive training gains in older adults: Insights from the ACTOP study. Cortex. 2024 Jul;176:221-233. doi: 10.1016/j.cortex.2024.04.013. Epub 2024 May 17.

  • Boujut A, Verty LV, Maltezos S, Lussier M, Mellah S, Bherer L, Belleville S. Effects of Computerized Updating and Inhibition Training in Older Adults: The ACTOP Three-Arm Randomized Double-Blind Controlled Trial. Front Neurol. 2020 Dec 3;11:606873. doi: 10.3389/fneur.2020.606873. eCollection 2020.

  • Boujut A, Mellah S, Lussier M, Maltezos S, Verty LV, Bherer L, Belleville S. Assessing the Effect of Training on the Cognition and Brain of Older Adults: Protocol for a Three-Arm Randomized Double-Blind Controlled Trial (ACTOP). JMIR Res Protoc. 2020 Nov 24;9(11):e20430. doi: 10.2196/20430.

MeSH Terms

Conditions

Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sylvie Belleville, PhD

    Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The experimenters are blind in the clinical trials. Participants know that there are different training programs but they ignore the purpose of each one.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Older participants are randomly assigned to one of three intervention conditions (Inhibition ; Updating ; General knowledge). Young participants only complete the initial assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research director of CRIUGM and full professor at University of Montreal

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 22, 2018

Study Start

October 19, 2017

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations