Clinical Trials Division

The Clinical Trials Division of the McCusker Alzheimer's Research Foundation Inc conducts clinical trials evaluating the effectiveness of pharmaceutical agents being investigated as therapeutic agents for Alzheimer’s disease.

The unit is under the supervision of Associate Prof Roger Clarnette, a senior specialist physician at Fremantle Hospital and Hollywood Private Hospital. As well as specialist medical qualifications Dr Clarnette has a PhD and particular interest in memory loss and Alzheimer's disease.

The Clinical Trials Division is permanently staffed by study co-ordinators with nursing qualifications and an administrative officer as well as sessional psychologists and medical practitioners who are involved in particular trials.

The Division is based at the Hollywood Specialist Centre. The clinical trials are conducted under the ethical codes of both the Foundation and Hollywood Private Hospital and are in accord with strict international standards.

The CTD is the pre-eminent site for trials into potential treatments for AD in Western Australia.

Current Trials

In 2008 we commenced our first trial of a group of drugs called human monoclonal antibodies. These medications may be disease modifying. The medication is given intravenously as a day procedure in Hollywood Hospital. Previously all medications were given orally or via an implant. We are hopeful this medication will be effective in clearing soluble beta amyloid from the brain and that in turn, this will have a beneficial impact on Alzheimer’s disease.

HPH 262: A Phase Two multicentre, Randomised, Double Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of multiple doses of PF-04360365 in patients with Mild-to-Moderate Alzheimer's disease
Protocol A9951002

Two patients are currently enrolled in and are continuing in the study. Both are in the follow period (final stages) of the study.

HPH 286: Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 in patients with moderate Alzheimer's disease treated with donepezil
Study 12936A

In 2010 the Clinical Trials Division screened seven patients for this study. A total of three patients were enrolled with four being deemed "screen failures". This reflects the exacting nature of the screening process and the work required to find sufficient numbers of trial participants. Recruitment for this trial has now been extended until June 2011.

By December 2010, a total of 227 patients had been screened worldwide and 163 patients had been randomised into the study, which is 60% of the target population. Dr Clarnette and the Clinical Trials Division were one of the highest recruiters worldwide.

HPH276: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer's Disease on Donepezil
Protocol DIM18

In 2010 the Clinical Trials Division screened 12 patients for this study. A total of four patients were subsequently enrolled and continue in the study. Recruitment has now been completed. In total 17 patients were enrolled at our site for this study.

14 patients have completed this DIM 18 study. Most patients have then proceeded into the Extension study (Concert Plus) although one patient opted not to participate. At the end of 2010 three remained in the main study.

HPH 290: A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000WW
Protocol 3133K1-3002-WW

HPH 291: A Phase 3 Extension, Multicenter, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer's Disease Who Are Apolipoprotein E ε4 Carriers and Participated in Study 3133K1-3001-WW
Protocol 3133K1-3003-WW

A total of four patients were enrolled into the extension studies above in 2010. One patient was enrolled into the 3002 study but withdrew in August 2010 at the request of the patient and the family. Three patients were enrolled into the 3003 study.

WN25203 Multicenter, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer’s Disease, and

WE25462 Research Project in association with Protocol WN25203 CSF sample retention for biomarker assay development.

Approval was received in late 2010 to recruit six patients and this is underway. The study commenced in autumn 2011 and will be conducted over the next two years.