Cleveland Clinic Keep Memory Alive Brain Health Registry:

Supported by the Caesars Foundation

Introduction

The Cleveland Clinic Keep Memory Alive Brain Health Registry (BHR) has two primary goals:

-  Raise awareness and spur action regarding brain health

-  Identify individuals who can participate in clinical trials to advance prevention, early detection and new therapies for Alzheimer’s disease (AD) and other brain disorders

The BHR is a critical element of a program to advance new therapies for Alzheimer’s disease (AD) and other brain disorders and to reduce the risk for these disorders among those currently unaffected. The program will provide information and trial opportunities to Caesars employees and their friends and relatives as well as reaching out nationally and internationally.

Brain Health

The brain determines every aspect of our lives – our thoughts, emotions, movements, and memory of who we are. Without the brain there is no self and no awareness of the world in which we live. Brain health is the basis of all other types of health and for all of human activity. Brain health is a paramount human goal.

Currently we often outlive our brains – our life span is longer than our brain span. Alzheimer’s disease doubles in frequency every five years after the age of 60 rising from 1% in 60 year olds to almost 50% in 80 year olds and even higher among the oldest old. This is the most rapidly growing segment of the US and of the Nevada population. Parkinson’s disease, stroke, brain cancer and brain trauma associated with falls all become more common in the aging population. Maintaining and protecting brain health can help to preserve memory and lower risk for brain diseases. A healthy and optimally functioning brain is essential to our well-being and quality of life.

Life style has a profound impact on brain health, unlike age and genes which cannot be changed, life style choices are under our control. Stay physically active, keep mentally engaged, eat smart with a Mediterranean-type diet, maintain social connectedness, minimize stress, get enough sleep and care for medical risk factors such as high blood pressure and high cholesterol. All these factors play important roles in keeping the brain sharp and healthy and reducing risk for brain diseases. Optimizing the brain health is a life time project; habits of brain health must begin early in life. Only by establishing brain healthy life styles can we expect to have a brain span that matches our life span.

Brain health is important from childhood through mid-life and into old age. Brain health is a work-force issue. Employees empowered with this knowledge can insure a healthier life for their children, themselves, and their parents. Employees with brain healthy life-styles are sharper, less prone to absenteeism, and more likely to remain with the company after training investments. The BHR is an interactive, engaging, web-based platform which will provide information to guide all participants and their families (including Caesars employees) with risk reduction tips and brain healthy life style enhancement tools. Get moving, keep sharp, eat smart, stay connected, rest well, and control medical risks are the six pillars of brain health. Participants will be given tools to guide interventions and to monitor their progress. These tools will include a brain health index that is moved by adding brain healthy activities or decreasing brain-unhealthy activities as well as on-line assessments and games which provide scores that can be followed over time.

The BHR will reach individuals across employers, occupations, ages, educational levels, and global regions. The BHR will include Caesars employees both locally in Las Vegas and internationally.

The BHR will build on the brand awareness and credibility of the Cleveland Clinic, ranked #1 in cardiovascular care in the US and 5th in neurological care. We will work with the Clinic Wellness Center to extend to brain health much of what they have done for cardiovascular health. “What is good for the heart is good for the brain” is true and allows us to incorporate the Clinic Daily Wellness Tip, product-related information, and exercise incentives to improve the brain health among BHR participants. With this background, we can “hit the ground running“.

Information on the BHR will be included in all Cleveland Clinic Lou Ruvo Center for Brain Health information. We will use media opportunities to raise awareness of the BHR. All community outreach activities of the Center (social work lectures, support groups, community talks, health fairs, etc.) will include information on the BHR. Opportunities will be sought to work with Caesars Foundation to place appropriate information in Caesars publications. Caesars Foundation will be recognized as a supporting partner of the BHR in all publications and media related to the BHR.

Clinical Trials

The Cleveland Clinic Lou Ruvo Center for Brain Health is a world leader in clinical trials, with over 20 trials in AD, Parkinson’s disease, and multiple sclerosis. Conducting clinical trials is the only way to gain FDA approval for any drugs and the only channel for making new treatments available to patients. The slowest and most expensive part of new drug development is clinical trials, in part because trials recruit patients at a slow rate and it takes many months to accrue enough patients to determine if the treatment is effective. One means of meeting this challenge and shortening recruitment times for trials is to have participants identified and ready to go before the trial starts. There is international recognition of the need for “trial ready” populations but few centers have found the resources to advance this critically important aspect of trials. The Cleveland Clinic Lou Ruvo Center for Brain Health can be a leader in identifying patients for their own trials and in demonstrating how this is done so that other centers can adopt our strategies, learn from our experience, and follow our example.

The BHR will collect information on participant age, education, sex, diagnosis, general health, and residence (zip code). They will explore interest in clinical trials and in being notified about research opportunities. They will be asked to complete on-line assessments that will help us understand if they qualify for trials. When new trials become available, we will notify those who are appropriate for the trial opportunity. Those from local zip codes can participate in Lou Ruvo Center trials whereas those in other zip codes can be acquainted with trials in other locations. Trials will be available to all BHR participants including Caesars employees and the parents and grandparents of Caesars employees who have evidence of brain disease.

The trials aspect of the BHR will advance new treatments for AD and other neurological diseases, provide trial opportunities to Caesars employees and their friends and relatives, and will advance the trial leadership position of the Lou Ruvo Center.

Overview

The BHR will serve the Lou Ruvo Center for Brain Health and will provide information on Brain Health to local, national, and international participants. All funds made available through the Caesars Foundation will stay in Las Vegas to be administered for this program by Jeffrey Cummings, MD, ScD, Director of the Lou Ruvo Center and a well-known leader in clinical trials. The program will be implemented by Kate Zhong, MD, Director of the clinical trials program and experienced clinical trials leader. Caesars Foundation employees will receive information on brain health and on clinical trial opportunities as part of our outreach program. The program is not limited to Caesars employees and will become a national and international guide to brain health and clinical trials. The important role played by the Caesars Foundation in supporting the BHR will be recognized in all publications and media presentations relevant to the BHR.

PROJECT EXPENSES
YEAR 1 / YEAR 2 / YEAR 3 / TOTAL
Development Costs
·  Website Design
·  Database Establishment
·  Survey Tool
·  Equipment and Supplies / $ 80,000 / $ 30,000 / $ 35,000 / $ 145,000
Personnel Costs
·  PM
·  Admin Assistant
·  Tech Consultant
·  Data Manager / $ 45,000
$ 45,000
$ 50,000
$ - / $ 70,000
$ 45,000
$ 25,000
$ 50,000 / $ 70,000
$ 50,000
$ 10,000
$ 55,000 / $ 185,000
$ 140,000
$ 85,000
$ 105,000
Operational Costs
·  Advisory Board
·  Marketing / $ 30,000 / $ 30,000 / $ 30,000 / $ 90,000
Total Expenses / $ 250,000 / $ 250,000 / $ 250,000 / $ 750,000

4