5 CBD research grants; NAP is focus of UCSF, UPenn, MayoRoch

In August ’08, it was announced that the Pollin family had given over $1 million to CurePSP to fund CBD research. (We discussed that here: http://forum.psp.org/viewtopic.php?t=7499)

CurePSP recently announced that a total of $1.15 million in research grants have been given to:
* Mt. Sinai School of Medicine, NY, Dr. Giulio Pasinetti
* University of South Florida, Tampa, Dr. Chad Dickey
* UCSF, San Francisco, Dr. Adam Boxer
* Duke University Med Ctr, Durham, Dr. Hana Dawson
* Cleveland Clinic, Cleveland, Dr. Kiran Bhaskar
(See http://www.psp.org/doc_library/1226690767/cbd%20pr.pdf for the short press release.)

The remainder of this post is about the research that will be conducted at UCSF, UPenn, and Mayo Rochester, hopefully beginning in April ’09.

Dr. Boxer, a neurologist at UCSF’s Memory & Aging Clinic, said that in the spring of 2009 UCSF intends to conduct a trial in CBD (and FTLD) patients with a drug called NAP. He needs to go through the UCSF IRB first as well as the FDA. The research project that Dr. Boxer will manage will potentially include two additional sites — UPenn (with whom UCSF has a close working relationship) and Mayo Rochester. UPenn and Mayo Rochester will also have to go through their IRBs.

(CBD folks can see some preliminary details that I posted recently on the CBD-related Yahoo!Group.)

I posted in late July about news out of the Alzheimer’s conference regarding the experimental drug Rember. (To re-live that news, see http://forum.psp.org/viewtopic.php?p=39893)

Like Rember, NAP is a tau-busting drug. It was also announced at the Alzheimer’s conference (ICAD) in Chicago. A trial of a NAP-derived compound called AL-108 was organized by a Duke University researcher. The drug was administered via a nasal spray for a twelve-week period in those with aMCI (amnesic mild cognitive impairment), thought to be a possible precursor to Alzheimer’s Disease. After four weeks of using the nasal spray, aMCI patients showed improvements in the ability to count backwards and to remember four objects. Here’s a short Good Morning America (ABC News) clip on this treatment from 7/29/08:
http://abcnews.go.com/GMA/story?id=5469940 (you may have to click on “Reload” to get this page to load properly)

The MD interviewed by GMA, Dr. Marie Savard, notes that it may be several years before we know if this treatment will be proven effective. This is still very early in the research into this drug. The GMA clip suggests people look on clinicaltrials.gov for trial info. I’m not sure why. The Duke-managed trial is listed but nothing else.

There is no published data on the Duke-managed human trial. There is published data on the mouse trial. You can find the abstract on pubmed.gov using PubMed ID# 18199809. (You can pay $10 to access the full journal article online.)

Allon Therapeutics, a Canadian company, is the manufacturer of AL-108. Here’s the company’s 7/30/08 press release on the AL-108 research:
You can also dig around on their website to find their ICAD ’08 presentation.

For an outside perspective, this Medscape Medical News article is worth reading:
The article points out that the results of the “12-week, phase 2a, double-blind, placebo-controlled study to evaluate the safety and tolerability of AL-108…showed that the drug had a positive effect on memory that was durable at 16 weeks in subjects randomized to the high-dose group (15 mg twice daily). However, the trial missed its primary efficacy end point — a composite of cognitive memory scores from the memory components of 4 cognitive tests — but did show a trend toward efficacy at weeks 8 and 16.” An Alzheimer’s researcher at Mayo Rochester was asked to comment on the trial. He noted that “(phase) 2 trials are not powered to show efficacy”; rather, they are designed to show if a medication is safe and tolerated.