Clinical Trials Division
The McCusker Foundation's Clinical Trials Division
facilitates the translation of research discoveries into publicly
available preventative and effective treatments for Alzheimer's
disease.
The Clinical Trials Division (CTD) was established by Dr Roger
Clarnette, Consultant Geriatrician at both Fremantle Hospital and
Hollywood Private Hospital. He transferred the CTD to the Foundation on 1st
July 2002. The purpose was to provide a clinical trials capacity to
test future research discoveries and to provide the Foundation with a
positive income stream which would add value to the research
effort. It currently trials the efficacy of drugs as potential
treatments for Alzheimer's disease on behalf of pharmaceutical
companies.
The CTD is under
the leadership of Dr Roger Clarnette (Principal Investigator), a
geriatrician with considerable experience in conducting clinical
trials. He is supported by a study coordinator and two part time
assistants.
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.
The Clinical Trials Division continues to be a vital part
of the search for treatments for Alzheimer's disease. The trials we
undertake are part of an international network testing the potential of drugs as treatments for Alzheimer's disease. The fact that a
small WA based group is considered sufficiently important to be
involved in these trials is testament to our efficiency and
effectiveness.
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.
New trials commenced in 2008:
- 3133K1-3000-WW-sponsor Wyeth
- Commenced April 2008: A phase III placebo controlled efficacy and safety trial of Bapineuzumab
in patients with mild to moderate Alzheimer's disease who are apolipoprotein E ε4
carriers/non-carriers.
- H6L-MC-LFAN-sponsor Eli-Lilly
- Commenced August 2008: A phase III 92 week placebo controlled study comparing the effect of
γ-Secretase inhibition on the progression of Alzheimer's disease in patients with mild to
moderate Alzheimer's disease.
- AZ3110866-sponsor GlaxoSmithKline
- Commenced August 2008: A fixed dose study of SB-742457 versus placebo when added to existing
donepezil treatment in subjects with mild to moderate Alzheimer’s disease.
- CENA713DAU01-sponsor Novartis
- Commenced September 2008: A 24-week open-label evaluation of compliance and tolerability of the
once-daily 10 cm² Exelon Patch formulation in patients with probable Alzheimer’s disease.
- E2020-G000-328-sponsor Eisai
- Commenced November 2008: Open-label Extension study of 23 mg Donepezil SR in patients with
moderate to severe Alzheimer's disease.
- A9951002-sponsor Pfizer
- Commenced Dec 2008: A phase II placebo controlled safety, tolerability and phamacokinetics of
multiple doses of PF-04360365 in patients with mild to moderate Alzheimer's disease.
Existing trials in 2008:
- MEM-MD-71 Trial sponsor Forrest Institute
- A placebo controlled evaluation of the efficacy of Memantine on functional communication in
patients with Alzheimer's disease.
- AVA102670 Trial sponsor GlaxoSmithKline
- A 58 week double blind, placebo controlled study to assess the efficacy and safety of RSG XR as
an adjunctive therapy in mild to moderate Alzheimer's disease.
- AVA102675 Trial sponsor GlaxoSmithKline
- A 52-week, open-label extension study of rosiglitazone extended-release) as adjunctive therapy
to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease.
- DEB-ZTSR-201 Trial sponsor Debioclinic
- An oral donepezil controlled study on the safety and efficacy of repeated monthly subcutaneous
injections of a sustained-release implant of ZT-1 in patients with moderate Alzheimer’s
Disease. This study which closed late 2008.
- A9951001 Phase 1 trial (Pfizer)
- A phase 1 placebo controlled study of the safety, tolerability, pharmacokinetics,
pharmacodynamics and immunogenicity of a single Intravenous dose of PF-04360365. 12 month study
in adults with mild to moderate Alzheimer's disease.
- E2020-G000-326 trial sponsor Eisai
- Double-Blind, Parallel-Group Comparison of 23 mg Donepezil SR to 10 mg Donepezil IR. 6 month
study in patients with moderate to severe Alzheimer's disease.
