Clinical trial NCT03600545: Brain Fitness APP for Aging With a Healthy Brain
Official title: Brain Fitness APP for Aging With a Healthy Brain and Detecting Cognitive Declines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Problems
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: AGE-WELL NCE Inc.
First posted: 2018-07-26
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: The change in Wechsler Memory Scale (WMS IV) from baseline
timeFrame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Secondary outcomes:
measure: Change in Egocentric Spatial Orientation
timeFrame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
measure: Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
timeFrame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Riverview Health Center
state: Manitoba
Study officials:
References: