Year: 2010 (Current)

Principle Investigator: Prof David Ames. Trials conducted by the Academic Unit for Psychiatry of Old Age, University of Melbourne.

Summary:

Objectives:

To assess change from baseline in the ADAS-Cog.

This is a phase 2 study.

Proposed mode of action of drug: Blocking of the 5-HT6 receptor.

Inclusion criteria:

• Participants with a diagnosis of Alzheimer’s disease
• Participants must have been on Donepezil (Aricept) for 4 months , stable for 3 months
• Recruitment Open

Sponsor: Lundbeck

Year: 2010 (Current)

Principle Investigator: Prof David Ames. Trials conducted by the Academic Unit for Psychiatry of Old Age, University of Melbourne.

Summary:

Objectives:

To see whether Dimebon given orally will slow the decline of AD compared to placebo as measured using the Alzheimer’s disease Assessment Scale- Cogniive subscore (ADAS-Cog) and Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL).

To evaluate the safety and tolerability of Dimebon at two doses: 20mg or 5 mg orally given three times a day.

This is a phase 3 study.

Proposed mode of action of drug: Stabilisation of the mitochondrial network and thus prevention of neuronal death.

Inclusion criteria:

• Participants with a diagnosis of Alzheimer’s disease
• Participants must have been on Donepezil (Aricept) for 4 months
• 4 patients recruited to date
• Recruitment continuing

Sponsor: Medivation and Pfizer

Year: 2010 (Current)

Principle Investigator: Prof David Ames. Trials conducted by the Academic Unit for Psychiatry of Old Age, University of Melbourne.

Summary:

Objectives:
To see whether Ly450139 given orally will slow the decline of AD compared to placebo as measured using the Alzheimer’s disease Assessment Scale- Cogniive subscore (ADAS-Cog)  and Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL).

To assess whether LY450139 will alter the accelerated rate of decline in brain volumes known to occur in patients with AD with the aid of MRI.

Proposed mode of action of drug:  inhibition of the enzyme gamma-secretase in order to stop the production of amyloid which has been implicated to play a role in the development of Alzheimer’s disease (AD)

This is a phase 3 study.

Inclusion criteria:

• Participants with a diagnosis of Alzheimer’s disease
• Participants must have been on Donepezil (Aricept) for 4 months and stable on it for 2 months
• 16 patients recruited to date
• Recruitment ended in July
• Open label extension phase commencing late September

Sponsor: Eli Lilly 

Year: 2004-05

Staff: Allan McLean, David Le Couteur

Summary: Adverse drug reactions (ADRs) are important in all ages, but emerging demographic change now requires focus on ADRs in older people. It has been estimated that ADRs are the fourth to sixth greatest cause of death, and as many as one in four hospital admissions of older people are related to the management of people suffering from drug-related toxicity. Classical determinants and mechanisms of ADRs apply, however there are particular issues in older age.

A focussed research and educational initiative is required to develop knowledge base for preventive programs in older people. Increased prevalence of adverse reactions in older people has a major impact on the generalisability of clinical trial evidence collected in younger adults. Indeed, the risk benefit ratio may be reversed for some older patients.

Summary: This trial is researching currently available and commonly used medications for cardiovascular disease known as angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (ARB's).

Funding source: Sponsored by Boehringer Ingelheim

Summary: This trial is studying the effects of Clopidogrel on reducing risk to cardiovascular disease complications.

Funding source: Sponsored by Bristol Myer Squibb

Summary: Trials are being conducted using memory enhancing medications included two using Galantamine in patients with very early memory problems and also in patients with mild to moderate dementia. It is hoped that this drug will improve the signs and symptoms associated with memory impairment.

Funding source: Sponsored by Janssen Cilag Pharmaceuticals

Summary: This trial is studying the effect of this new antipsychotic drug to treat psychosis in patients with Alzheimer's diseases already in permanent care.

Funding source: Sponsored by Bristol Myer Squibb

Summary: This trial is comparing the effect of Aricept and Exelon in improving cognitive function and behavioural problems in patients with dementia.

Funding source: Sponsored by Novartis Pharmaceuticals

Summary: This trial is investigating the effect of cholesterol lowering drugs (statins) in combination with Aricept on the development and progression of Alzheimer's disease.

Funding source: Sponsored by Pfizer Pharmaceuticals