• Synaptogenix, an emerging biopharmaceutical company working on treatments for brain-related disorders, recently shared findings from their Phase 2 trial on a drug called Bryostatin-1 for Alzheimer’s disease.
  • The results of a recent phase 2 clinical trial indicate that Bryostatin-1 may halt cognitive decline in patients with severe Alzheimer’s, in contrast to placebo recipients who demonstrated a drop in cognitive function.
  • This novel drug has previously shown potential in lab settings, bolstering brain connections and offering protection against Alzheimer’s-related proteins.

A new study published in the Journal of Alzheimer’s Disease — covering a phase 2 clinical trial spearheaded by scientists affiliated with the biopharmaceutical company Synaptogenix — looked at how Alzheimer’s patients responded to a a new experimental drug, Bryostatin-1 over 6 months.

For those with severe Alzheimer’s, the drug seemed to prevent further cognitive decline when compared to those on a placebo, who showed a drop in their cognitive scores.

In recent laboratory studies, a compound known as Bryostatin has shown promise in supporting brain connections and combating signs of Alzheimer’s disease.

Drug may protect brain cells from premature death

With a molecular weight of 904, the experimental drug appeared to enhance neural connections, protect brain cells from premature death, and counteract harmful proteins linked to Alzheimer’s.

The primary aim of the recent trial was to determine if Alzheimer’s patients could benefit cognitively from regular doses of Bryostatin compared to a placebo.

Researchers observed 122 Alzheimer’s patients over 6 months. These participants were divided into two main groups based on the severity of their cognitive impairment, as measured by the Mini-Mental Status Exam (MMSE).

One group had moderate cognitive impairment, scoring between MMSE 15-18, and the other had more severe impairment, scoring between MMSE 10-14.

To ensure a fair comparison, patients were grouped according to their initial cognitive scores.

This 6-month test randomly divided patients, giving some Bryostatin-1 and others a placebo. The goal was to see how effective Bryostatin-1 is in treating severe Alzheimer’s without using another drug called memantine.

The results showed that while some patients did not see much change, those with severe Alzheimer’s showed a noticeable improvement in brain function from about 3 to 10 months, with the last treatment given around 6 months.

Participants with severe Alzheimer’s showed cognitive improvements

Those in the more severe impairment group who were treated with Bryostatin showed noticeable cognitive improvements from the 13th to the 42nd week of the trial.

Importantly, these benefits persisted even 16 weeks after the last dose was administered.

On the other hand, patients in the same group who received the placebo experienced a decline in their cognitive abilities, dropping by an average of 12.8 points by the end of the study.

When looking at trends, the placebo group’s decline was significant, while the Bryostatin group remained relatively stable. At the same time, the group with moderate cognitive impairment did not experience any noticeable benefits from the treatment.

In conclusion, for patients with more severe cognitive impairment, Bryostatin appeared to stave off cognitive decline during the 10-month trial, whereas those on the placebo saw a significant drop in their cognitive scores.

Dr. Alan Tuchman, CEO of Synaptogenix, spoke to Medical News Today, saying that the team’s “most recent study strongly suggested that, in a cohort of severe Alzheimer’s patients, improvement was seen over the course of 42 weeks as compared to placebo.”

The trial also found that the intervention was safe, the researchers noting that most of the adverse events observed during the trial were related to the experimental treatment.

“This result, if confirmed in further trials, would offer hope to patients currently suffering from severe Alzheimer’s disease and their families as no treatment for this group is currently available,” Dr. Tuchman noted.

Interesting results, but more research needed

Dr. Clifford Segil, neurologist at Providence Saint John’s Health Center in Santa Monica, CA, not involved in this research, said: “I had not heard of Bryostatin being tried as a treatment for humans with memory loss, and I looked up […] ‘Bryostatin’ to see if it was a vitamin or mineral, and assumed it was related to other ‘statin’ medications where are commonly used cholesterol lowering medications.”

“For example atorvastatin is a commonly used medication, [sold under the brand name] Lipitor, used to lower cholesterol in people’s blood with the goal of decreasing a stroke or heart attack [risk],” Dr. Segil noted.

“The mechanism of action of these bryostatins is different [from that of statins], and they are protein kinase C inhibitorsTrusted Source,” he explained. Researchers have been studying protein kinase C inhibitors in the treatment of cancer, neurological conditions, and cardiovascular disease.

Nevertheless, Dr. Segil admitted: “It is challenging for me to agree any substance can be synaptogenic, which means [it] make[s] new nerves grow in the brain due to new synapse or connections between brain nerves or neurons.”

“It is equally challenging to agree any substance can be anti-apoptotic, which is when certain cells need to die to make way for new cells to grow, similar to a tree leaves having to die to make way for new leaves to grow. These are big claims for any substance and I remain in waiting for the world to find something that is truly synaptogenic and anti-apoptotic.”

Dr. Clifford Segil

Although further studies are required, Dr. Segil highlighted that “substances like these bryostatins should be used more to determine if they have clinical efficacy in treating patients with memory loss.”

“I am fascinated that this study noted bryostatins seemed to help patients with severe memory loss with a MMSE score of 10–14 out of 30 more than it helped patient with a little better severe memory loss or patient with MMSE scores of 15–18. I think bryostatins are a very reasonable substance to be further tested in neurological diseases,” he concluded.