RespireRx Pharmaceuticals Inc (fka RSPI)

[Aiming4]

Shareholder letter excerpt on AD trial delay:

The clinical trials are moving ahead, but clearly patient enrollment has slowed down some of the trials which we had hoped would get us some additional results quickly. Namely, the PET scan study in Alzheimer’s patients has had extremely slow enrollment. In part our study has been impacted by a general slowdown in the recruitment rates for US-based Alzheimer’s disease studies. The major reasons for the slowdown include large numbers of competing clinical trials and the widespread use of memantine in combination with cholinesterase inhibitors such as Aricept®. The complexity and intensity of our trial also turned out to be a barrier to entry of subjects. Our protocol allowed for the concomitant use of cholinesterase inhibitors, but not for the use of memantine. This apparent rapid rise of memantine usage in Alzheimer’s patients was not envisioned by any of the investigators with whom we worked. We now know it will be sometime in early 2006 when we may actually get results from the Alzheimer’s PET scan study. This means that the other trials will also be complete by that time. The recruitment for the ADHD study has been much more positive and moved along expeditiously and the shift work study also has been initiated and should move along at a pace consistent with obtaining results in early 2006.