Brain Fitness APP for Aging With a Healthy Brain

Memory Problems Clinical Trial

Official title:

Brain Fitness APP for Aging With a Healthy Brain and Detecting Cognitive Declines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600545
• Other study ID #: B2018:029
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: February 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The research is on the frequent use of our designed APP (for iPADs) that contains a series of our recently developed brain exercises that contains a series of our recently developed brain exercises, including orientation, associative memory, word-image association, recall memory, etc.

Participants will be randomly assigned to either Intervention or Control Arm. Participants of Intervention Arm must have access to an iPAD at least for the duration of the study.

Procedure for Intervention Arm The participants in Intervention Arm will have a training session (after obtaining their consent form) for the Brain Exercises. The Brain Fitness App will be downloaded into their iPAD and they will be instructed on how to use it. As mentioned in their consent form, they will commit themselves to play the games on a daily basis for (at least 5 days/week), twice/day, each session of minimum 15 minutes for a period of 4 consecutive weeks.

Procedure for Control Arm Participants of this arm will do nothing but will be assessed at baseline, 4 week and 8 weeks later. Their data will be used as the control data for comparison with the Intervention Arm data. All participants of this group, if interested, will be offered to practice the Brain Fitness App if they wish after their completion of this study (2 months period).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Memory Problems

Intervention

Other:
• Brain Fitness App
Brain exercises using an iPAD

Locations

Country	Name	City	State
Canada	Riverview Health Center	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	AGE-WELL NCE Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Egocentric Spatial Orientation	This test is one of the PI's designs that has been in use since a few years ago. It is used for detecting the onset of Alzheimer's. In this test participants sit in a customized wheelchair and by waking the wheelchair they move within a virtual cubic building to reach a particular target room. They can do this test either using the laptop screen or in its immersive version wearing a goggle (Oculus Rift 2).	baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Secondary	Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)	The MADRS is a ten item rating scale for rating levels of depression. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates absence of the symptom and 6 indicates extreme presence of the symptom. The time frame for the scale is the previous four weeks.	baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment