NCT03883308

Brief Summary

The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment (MCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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 30, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

March 18, 2019

Last Update Submit

May 3, 2021

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Executive function composite score

    The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency

    6 months

  • Executive function network connectivity

    The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.

    6 months

Secondary Outcomes (3)

  • Memory function composite score

    6 months

  • Medial temporal network connectivity

    6 months

  • White matter integrity in memory circuit

    6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.

Behavioral: Multi-domain cognitive training

Active Control

ACTIVE COMPARATOR

The Active Control group will receive 6 months of online, computerized cross-word puzzles at home using the same platform as for the Treatment group.

Behavioral: Cross-word puzzle training

Interventions

Multi-domain cognitive trainingBEHAVIORAL

The cognitive exercises are designed to train executive functions and memory.

Treatment
Cross-word puzzle trainingBEHAVIORAL

The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.

Active Control

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Cognitive concern by subject, informant or physician
  • Impairment in memory domain (delayed recall of one paragraph from Logical Memory II subscale from Wechsler memory Scale - Revised with cutoff scores of \<=8, \<=4 and \<=2 for 16, 8-15 and 0-7 years of education)
  • Essentially normal functional activities
  • Mini-Mental State Examination (MMSE) scores \>=24
  • Stability of permitted medications (e.g. cholinesterase inhibitors, hypertension medication, etc.) for at least two months.

You may not qualify if:

  • Any significant neurological condition including probable dementia, Parkinson's disease, Huntington's disease, multiple sclerosis, and brain tumor, among others.
  • Presence of Axis I disorder
  • Current use of psychoactive medications except for the permitted medications.
  • Claustrophobia
  • MRI contraindication
  • Any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Gozdas E, Avelar-Pereira B, Fingerhut H, Dacorro L, Jo B, Williams L, O'Hara R, Hosseini SMH. Long-term cognitive training enhances fluid cognition and brain connectivity in individuals with MCI. Transl Psychiatry. 2024 Oct 23;14(1):447. doi: 10.1038/s41398-024-03153-x.

    PMID: 39443463DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

October 30, 2017

Primary Completion

September 30, 2020

Study Completion

December 1, 2020

Last Updated

May 5, 2021

Record last verified: 2021-05

Locations

US(1)