Neurotrope is launching a long term Phase 2 trial of Bryostatin-1, which is a treatment for Alzheimer’s disease. The National Institutes of Health (NIH) will be joining this study, giving a $2.7 million grant. Researchers are not only hopeful that this treatment will be successful with Alzheimer’s, but they believe that positive results could translate to other conditions such as multiple sclerosis and fragile X syndrome.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive disorder that causes the degeneration and death of brain cells. It occurs in stages, with severity increasing as time goes on. In the later stages of the disease, people will experience significant memory loss and be unable to carry out everyday tasks.
The major symptom of this condition is memory loss. Other issues that people experience include problems with thinking and reasoning, making judgments and decisions, planning and completing familiar tasks, and more. They will experience changes in personality and behavior. Other complications can also arise from Alzheimer’s, such as aspiration, pneumonia, infections, falls, fractures, bedsores, malnutrition, and dehydration.
Medical professionals believe that Alzheimer’s is caused by a combination of genetic, environmental, and lifestyle factors. In the case of the form of Alzheimer’s being studied by Roche, it is caused by genetic factors that are inherited in an autosomal dominant pattern. What healthcare professionals do know is that brain cells deteriorate and die. They also suspect that plaques and tangles, which are both proteins, play an important role.
There are risk factors that may heighten the chances of developing Alzheimer’s disease. Age is a major factor, as people usually develop this condition after 65. If one has a relative that is affected, they are also at a higher risk. Females are also affected at a higher rate than males. Those with past head trauma, poor sleeping patterns, poor exercise patterns, or other unhealthy lifestyle habits have a higher chance of Alzheimer’s disease.
Doctors will typically diagnose Alzheimer’s disease after a finding of characteristic symptoms. Tests will be used to confirm a diagnosis, such as a physical and neurological exam and brain imaging, like MRIs and CT scans. After it is confirmed that one has Alzheimer’s, treatment typically consists of cholinesterase inhibitors and memamtine.
About the Study
Around 100 participants are expected to enroll in this trial, all of whom have a moderate to severe case of Alzheimer’s. They will take part in two 11 week dosing cycles. Patients will only be given Bryostatin-1; researchers will not be administering Namenda, which is a major treatment of dementia associated with Alzheimer’s.
Results will be evaluated on the Severe Impairment Battery (SIB) scale, as this scale is widely accepted in assessing cognitive benefits. Neurotrope hopes to begin their trial at the end of the third quarter or beginning of the fourth quarter this year.
This trial comes after the positive results of a shorter pilot study. Through the course of 11 weeks, patients were given Bryostatin-1 instead of Namenda. The former was well-tolerated and resulted in a 5.0 improvement on the SIB scale.
Researchers hope that similar positive results will come from the longer-term study. In fact, experts believe that this medication could change the way in which medical professionals treat AD.
