A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age
This research study is investigating a new medicine, BIIB080, for people aged 50 to 80 who have early Alzheimer's disease or mild memory loss linked to Alzheimer's. The main goals are to check if BIIB080 is safe and if it can slow down the disease's progression, compared to a placebo (a dummy medicine with no active drug). Researchers will also look at which dose might be most effective. The study involves two parts: an initial period where participants receive BIIB080 or placebo, followed by a longer period focusing on the medicine's long-term safety and effects on daily life and thinking abilities. Participants will receive injections into their spinal fluid.
At a glance
What is this study about?
This study is about a new investigational medicine called BIIB080. It's being tested for people who are experiencing early stages of Alzheimer's disease, including those with mild memory and thinking problems (often called mild cognitive impairment due to Alzheimer's) or mild Alzheimer's dementia. The reason for this study is to see if BIIB080 can help slow down the changes in memory and thinking that happen with Alzheimer's disease.
The main questions researchers are trying to answer are: Is BIIB080 safe for people to take? And can it slow down the worsening of Alzheimer's symptoms more effectively than a placebo (a treatment that looks like the medicine but contains no active drug)? They will also explore which dose of BIIB080 might work best. To measure this, doctors will use a special scoring system to track changes in memory, problem-solving, and daily activities.
Understanding how new medicines like BIIB080 work and if they can help people with Alzheimer's is really important. This study hopes to provide valuable information that could lead to new ways of managing the disease in the future. Remember, taking part in a study is a big decision, and it's always good to discuss it thoroughly with your own doctor.
Key takeaways
- This study investigates a new medicine, BIIB080, for early Alzheimer's disease.
- It aims to check safety and if BIIB080 can slow memory and thinking decline.
- Participants will receive injections into their spinal fluid, some receiving a placebo initially.
- The study involves regular clinic visits and can last up to four years.
- A care partner is needed to help provide information about daily abilities.
Who may be eligible?
This study is looking for people aged between 50 and 80. To join, you would need to have been diagnosed with mild memory problems due to Alzheimer's disease or mild Alzheimer's dementia.
Doctors would check your memory and thinking abilities carefully using specific tests to make sure your symptoms fit the study requirements. You would also need to show signs of Alzheimer's disease in your brain, which they can check through scans or by looking at your spinal fluid.
It's important that you have a care partner, such as a family member or close friend, who spends at least 10 hours a week with you. This person would help the study team understand how your memory and daily activities are changing. If you've been taking other Alzheimer's medications, you'd need to have been on a stable dose for at least eight weeks before joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 50 and 80 years old?
- Have you been diagnosed with mild memory problems due to Alzheimer's or mild Alzheimer's dementia?
- Do you have a care partner who sees you at least 10 hours a week?
- Are you able to attend regular clinic visits and have spinal fluid injections?
- If taking other Alzheimer's medicines, have you been on a stable dose for at least 8 weeks?
What does participation involve?
If you decide to take part, the study will last about four years in total. It starts with an initial check-up to see if you're suitable. Once enrolled, you would receive the study medicine, BIIB080, or a placebo (a dummy medicine), through an injection into the fluid around your spinal cord. These injections would happen either every 12 weeks (about every three months) or every 24 weeks (about every six months).
For the first 76 weeks, you wouldn't know if you're getting the active medicine or the placebo. After this initial period, if you're still eligible and wish to continue, you could enter a longer-term part of the study for another 96 weeks. During this extension, everyone would receive the active BIIB080 medicine. Most participants would need to visit the clinic about every six weeks after the initial screening period for checks and assessments. You can continue taking certain other Alzheimer's medications, but the dose must be stable before starting the study.
Potential risks and benefits
Locations (138)
- Xenoscience Inc.Verified postcodePhoenix, United States
- HonorHealth NeurologyVerified postcodeScottsdale, United States
- Banner Sun Health Research InstituteVerified postcodeSun City, United States
- Center for NeurosciencesVerified postcodeTucson, United States
- Mary S. Easton Center for Alzheimer's Disease Research, UCLAVerified postcodeLos Angeles, United States
- PNS Clinical Research, LLC dbaVerified postcodeOrange, United States
- Stanford Hospital and ClinicsVerified postcodePalo Alto, United States
- Sutter Institute for Medical ResearchVerified postcodeSacramento, United States
- University of California San Diego Medical CenterVerified postcodeSan Diego, United States
- University of California San Francisco (PARENT)Verified postcodeSan Francisco, United States
- Rocky Mountain Movement Disorders Center, PCVerified postcodeEnglewood, United States
- Charter Research, LLCVerified postcodeLady Lake, United States
Common questions
What is BIIB080?
BIIB080 is an experimental medicine being tested to see if it can help slow down Alzheimer's disease.
How is the medicine given?
The medicine is given as an injection into the fluid around the spinal cord.
Will I know if I'm getting the real medicine or a placebo?
For the first part of the study, you won't know if you're getting the real medicine or a placebo (a dummy medicine).
How long does the study last?
The study could last up to about four years, including all visits and follow-ups.
Can I still take my other Alzheimer's medicines?
Yes, you can usually continue taking certain other Alzheimer's medications, but your doctor will check if they are suitable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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