Is there room for a novel vaccine for Alzheimer's disease?

At the moment, the biggest focus in treating Alzheimer's disease pharmacologically is by using monoclonal antibodies.  Aduhelm, BAN2041, and any treatment candidate with "mab" in its name (e.g. aducanumab) use antibodies originally derived from elderly humans who had developed and deployed the antibodies against beta amyloid accumulating in plaques in their brains.  The derived antibodies are grown and reproduce in the laboratory, and Alzheimer's patients subsequently receive the laboratory-produced antibodies through monthly or biweekly infusions.  At least in the cases of Aduhelm and BAN2401, these antibodies are effective in removing beta amyloid plaques from the brains of Alzheimer's disease patients.  (We continue to look for better evidence to verify the effectiveness of the treatments in significantly moderating the progress and consequences of the disease.)

But is this the only way to clean the brain of amyloid plaques?  A company called Alzamend Neuro, Inc. thinks not.  They would like the patient to develop their own antibodies via a very unusual vaccination process.

Alzamend has developed a method by which they take some of the patient's own immune cells and teach them in the laboratory to recognize beta amyloid molecules.  The cells are returned to the patient's body, where they prompt the immune system to attack the amyloid plaques.  The treatment is code-named ALZN002.

Is this better than monoclonal antibodies?  Based on tests with mice, the treatment appears to be longer lasting and safer than the "mabs."  The claim that it's safer is based on the fact that ALZN002 is using the patient's own cells and so should avoid rejection.  (I don't know what they predict with respect to the microhemorrhaging that plagues the mabs.)

So where does this project stand?  So far, it has only been tested in mice.  But these tests went remarkably well, both from the standpoint of removing amyloids from mouse brains and a lack of adverse side effects.  The next step is to begin human trials.

In this press release, Alzamend announced that they had applied to the FDA for the first US trial of ALZN002.  Normally, the first step would be a phase I trial involving 20 to 80 people, followed by a phase II trial involving several hundred subjects.  The first purpose of the phase I trial is to assess the safety of the treatment, and, in this case, to establish the appropriate dose.  The phase II trial takes a harder look at whether the treatment works or not and may involve several hundred subjects.  

But Alzamend has applied for a combined phase I/IIa trial.  This is not unusual, but I don't know the details of how the trial will be designed.  Alzamend, of course, is hoping for prompt approval of their application so that they can move ahead with the trial.