NCT03600545

Brief Summary

Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. While currently there is no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy life style. The proposed research offers a novel approach to prevent dementia and age-related cognitive disorders. It is proposed to create a brain fitness APP for the aging population. The proposed APP is based on the premise of brain plasticity, and targets the brain functions that are declining with normal aging and dementia. The proposed APP will be tested on a large population with statistical rigor (60 healthy individuals of age 65+ years and up to 30 individuals with cognitive impairment); the participants will be divided into an intervention group and a control group. We will analyze the logged performance of the participants, and assess their cognitive state with an independent test compared to a matched control group before and after the trial. It is anticipated that the frequent use of the proposed APP will help to maintain a healthy brain as well as detecting the onset of a cognitive decline in aging population. In addition, its frequent use will slow and even reverse the progression of the cognition decline in individuals with mild cognitive impairment or dementia. The APP will have many different levels of difficulty so that it can be applied to a wide age range and conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

April 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

April 11, 2018

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change in Wechsler Memory Scale (WMS IV) from baseline

    This assessment has a total of 11 tests, out of which we will use its six primary tests that assess our target brain functions, comprised of 12 subtests (subsections): Logical Memory 1, Verbal Paired Associates 1, Faces 1, Family Pictures 1, Logical Memory 2, Verbal Paired Associates 2, Faces 2, Family Pictures 2, Verbal Paired Associates 2 Recognition, Logical Memory 2 Recognition, Letter-Number Sequencing and Spatial Span. They are classified into 3 major memory indexes: Immediate Memory, General Memory and Working Memory. The WMS test is being purchased online from the following link; they do not provide a softcopy.

    baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment

Secondary Outcomes (2)

  • Change in Egocentric Spatial Orientation

    baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment

  • Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)

    baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment

Study Arms (2)

Active

EXPERIMENTAL

4 weeks daily practice of the brain exercises

Other: Brain Fitness App

control

NO INTERVENTION

no brain exercises

Interventions

Brain exercises using an iPAD

Active

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • MoCA ≥ 25
  • Have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, dementia of any type, or any other neurological degenerative disease.
  • Capable of using an iPAD and access to Internet at home.
  • Reading/writing fluency in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

July 26, 2018

Study Start

June 20, 2018

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations