Alzheimer’s disease is one of the most common types of dementia, caused by damage to the tissue in the brain. The risk of developing Alzheimer’s disease increases with age, and it is estimated that more than 35 million people are currently diagnosed with the disease worldwide, and the numbers are steadily increasing. The disease often progresses slowly in the early stages, where it causes short-term memory loss. As the disease progresses, the cognitive and functional abilities decrease, and eventually, patients with Alzheimer's disease require around-the-clock care where help with basic daily activities is required.
No known cure for Alzheimer’s currently exists, but different treatments are available that in some cases can reduce the symptoms of Alzheimer’s disease temporarily. These care options are used to reduce cognition and behavioral symptoms but until now, only modest benefits have been found.
Due to limited care options for Alzheimer's disease, there is a need for new treatments for patients diagnosed with Alzheimer’s disease. The aim of this study is to assess the safety and efficacy of a new treatment for early-stage Alzheimer’s disease. If you or any of your loved ones are suffering from Alzheimer's disease you might qualify for the study. If you qualify for participation in the study, you might receive a placebo instead of the study medication. A placebo is provided instead of the study medication and contains no active ingredients. The use of a placebo is standard practice in research studies investigating the effect of study medications and is used as a measure of comparison. Your chance of receiving a placebo will be explained by the study staff in advance of your participation.
Who can participate?
Candidates who fulfill the following criteria may be eligible for the study:
- Male and female between 50-85 years
- Have a diagnosis of Alzheimer’s disease
- Are diagnosed with early-stage Alzheimer’s disease
- Boca Raton
- Elk Grove Village
- Lady Lake
- Neptune City
- New Port Richey
- New York
- Palo Alto
- Port Orange
- San Antonio
- Winter Park
The study drug and any tests required by the study are provided by the study team, and you may receive reimbursement for travel related expenses incurred by taking part in the research study until your participation is complete.
The research study assesses the risk and benefits of the study drug in treatment of early Alzheimer’s disease. If you are interested and qualify to participate, staff at a study site will provide you with a detailed overview of the steps required to participate before you agree to take part in the study. You must have a study partner available, who can be present at consultations and help with any information about your general health the study staff might need. The staff will take time to review any questions you and your study partner might have before entering the study.
The duration of study participation is approximately 115 weeks, in three following periods:
A screening assessment period
The first period you will enter, is a screening period. In this period both clinical and laboratory assessments will confirm your eligibility. For the screening session, you and your study partner will receive information about the research study, and you will have to visit a study site up to two months before you may receive the study medication. At the screening visit, staff will ask you and your study partner some questions about your health and perform some tests (e.g., blood test, cognitive tests, measure body weight and height, MRI, PET, etc.) and an informed consent form must be signed. You can, however, always withdraw your participation.
If you are eligible to participate in a study after the screening period, you will enter a treatment period. The length of the treatment period would maximum be 96 weeks. Here you will receive either a study medication or a placebo. Both the study treatment and the placebo are administrated as an injection which you will receive at a local hospital every 4 weeks.
After termination of the study treatment, you will enter a 8-week post-treatment follow-up period. During this period, you will visit the local site twice for some final assessments. Your health will be closely monitored by study staff throughout your participation in the research study. You can withdraw your participation at any time without providing any reason.
In the figure below, you can see the maximum duration of the different periods of the research study.