NCT03263247

Brief Summary

The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

7 years

First QC Date

August 24, 2017

Last Update Submit

May 10, 2023

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Changes in functional magnetic resonance imaging (fMRI)

    fMRI correlates of behavioral performance

    Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance

  • Changes in memory and language measures

    Improvement in Logical Memory Test I and II results and naming tests

    Baseline and after 4 weeks of intervention - generalization

Secondary Outcomes (1)

  • Changes in perception of memory performance

    Baseline, within four weeks after intervention

Study Arms (3)

Visual Imaging Training

EXPERIMENTAL

Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions

Behavioral: Memory Training

Psychoeducation

ACTIVE COMPARATOR

Participants will receive information about memory functioning and aging. Intervention: behavioral: Psychoeducation in individual sessions

Behavioral: Psychoeducation

Alphabet Search

EXPERIMENTAL

Participants will receive alphabet search training. Intervention: Alphabet Search in individual sessions

Behavioral: Alphabet search

Interventions

Memory TrainingBEHAVIORAL
Visual Imaging Training
PsychoeducationBEHAVIORAL
Psychoeducation
Alphabet searchBEHAVIORAL
Alphabet Search

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent.

You may not qualify if:

  • History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr Eliane C Miotto

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

January 2, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

BR(1)