The Alzheimer’s DAYBREAK-ALZ Study is a clinical research study for people with memory problems or mild Alzheimer’s disease. We are looking for people who would like to participate.

Alzheimer’s is a type of dementia that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks. As we get older, most of us become more forgetful. Keys go missing, we can’t remember names easily, memories fade. But if you find that forgetfulness is becoming a problem for you, people comment on your memory loss, or you have difficulty planning or problem-solving, these could be early signs of Alzheimer’s disease.

Alzheimer’s disease is very common, it affects one in 1,400 who are age 40-64 years, one in 100 people age 65-69 years, one in 25 of people in their 70s, and one in 6 of people age 80 years or older.

Symptoms of Alzheimer’s disease include memory loss, difficulties thinking, problem-solving and communicating. Alzheimer’s disease develops due to changes in the structure and chemistry of the brain that affect its ability to function properly when performing certain “mental” activities. This is known as cognitive impairment.

Alzheimer’s has no current cure, but treatments for symptoms are available and research continues.

Although current Alzheimer’s treatments cannot stop Alzheimer’s from progressing, they can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer’s and their caregivers.

Dr. Bhatia’s clinic is conducting Alzheimer’s DAYBREAK-ALZ Study in Fresno

Do you or a loved one have memory problems or mild Alzheimer’s disease?

Then you may be interested in the DAYBREAK-ALZ clinical research study.

• The DAYBREAK-ALZ study is a clinical research study for people with memory problems or mild Alzheimer’s disease.
• The study will examine if an investigational medication, taken by mouth, may slow the decline in memory and mental functioning associated with Alzheimer’s.
• There is no cost to participate. Volunteers who take part in the study will receive all study-related care, from a Specialist Physician, at no cost and you may be compensated up to $150 per visit for your time and travel expenses.

Who can join the DAYBREAK-ALZ Study?

To join the study you must:

• Be between 55 and 85 years old
• Have a close friend, relative or partner who would be willing to be your study partner throughout the study
• Have experienced a gradual loss of memory over the last 6 months (the study team will assess whether this is due to Alzheimer’s disease) or have been diagnosed with mild Alzheimer’s disease

Interested?

If you think you might like to join the DAYBREAK-ALZ study or you would like to learn more, please contact us. We can tell you more about it and explain what participating would mean for you. We will talk through the potential benefits and risks of being involved in the study, before you make your decision about joining.

We will also carry out several medical checks to see whether you are right for the study, and the study is right for you.

What does the study involve?

The study will last for around three years – 8 weeks to see if you qualify, plus 3 years of treatment, then 4 weeks of follow-up.

The study drug is a tablet, to be taken once a day. The tablet will contain either a lower dose of the study drug, a higher dose of the study drug, or a placebo, depending on which group you are assigned to. A placebo tablet is one that contains no active ingredients.

You will be assigned at random to one of the study groups. Neither you nor the study doctor will know which group you’ve been assigned to. There is a 2 in 3 chance that you will receive the study drug. If it is necessary to find out which group you’ve been assigned to, the study doctor can do so quickly.

You will need a study partner. This person needs to be someone who you are in regular contact with, who will go with you to study appointments, and who can help the study team to notice any changes in your mental functioning.

If you join the study, you and your study partner will be asked to attend around 29 appointments. During these appointments, we will assess your health, thinking and memory with some standard medical tests and questionnaires. We will also ask you about any side effects you may experience. These appointments will be every 3 weeks for the first few visits and then every 7 weeks until the end of the study.