A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily)with background therapy of donepezil (5mg or 10mg).An interim analysis is planned to assess futility of the low dose group (1mg) and to allow the opportunity to evaluate a higher dose level (30mg) in a separate group of patients. The anticipated time on study treatment is 3-12 months. CLICK HERE FOR MORE INFO

A fixed dose study of SB-742457 versus placebo when added to existing
donepezil treatment in subjects with mild-to-moderate Alzheimer's disease

This study is a 24 or 48 week, double-blind, placebo-controlled study to assess the efficacy and safety of once daily dosing of SB-742457, an investigational drug, as an add-on to stable donepezil treatment in subjects with mild-to-moderate probable Alzheimer’s disease (AD). CLICK HERE FOR MORE INFO

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease
This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. CLICK HERE FOR MORE INFO

C5R sites participating in this study Contact Site Address Lisa McAvoy Tel :613-544-3400 Ext: 3320 Fax: 613-542-9505 Dr. Angeles Garcia Principal Investigator Hotel Dieu Hospital 166 Brock Street, JM3, Rm 302 Kingston, ON  K7L 5G2 Olivia To Tel: 519-685-4292 Ext: 42677 Sarah Best Tel: 519-865-4292Ext: 42567 Fax: 519-685-4558 Parkwood Hospital 801 Commissioners Road East London, ON  N6C 5J1 Dr. Andrew Frank Tel: 613-562-6322 Fax: 613-562-6013 Memory Disorder Clinic Elisabeth Bruyere Health Centre 75 Bruyere Street Room 216Y Ottawa, ON  K1N 5C8 Vicki Giardino, CCRP Tel: 416-386-9761 Fax: 416-386-0458 Toronto Memory Program 1 Valleybrook Drive, Suite 400 Toronto, ON M3B 2S7 Behnaz Ghazanfari Tel: 416-603-5800 Ext. 3406 Fax: 416-603-5768 Toronto Western Hospital 399 Bathurst Street 5ww-room 423 Toronto, ON  M5T 2S8 or Whitby Mental Health Centre 700 Gordon Street Building 2, Level 2, Memory Clinic Whitby, ON  L1N 5S9 Dr. Ziad Nasreddine Principal Investigator Tel: 450-672-7766 Fax: 450-672-1442 Clinique Neuro Rive-Sud 4896 Blvd Taschereau, Suite 250 Greenfield Park, QC J4V 2J2 Nicole Lachance Tel.:514-252-3400 Ext: 3298 Fax:514-259-6755 Recherche clinique de neorolgie 5305 Boul. L'Assomption #4120 Montreal, QC  H1T 2M4 Chris Hosein, M.Ed, CCRP Tel: 514-340-8222 Ext: 3621 Fax: 514-340-7547 Jewish General Hospital Memory Clinic 3755 Côte-Sainte-Catherine Road Montreal, QC  H3T 1E2 Dr. N. V. P. Nair Tel. (514) 762-3035 Fax (514) 762-3020 Douglas Mental Health University Institute Human Psychopharmacology Trials 6875 Lasalle Blvd., Montreal, QC H4H 1R3

ELND005 in Patients With Mild to Moderate Alzheimer's Disease
ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for Alzheimer's disease (AD). ELND005 may prevent or inhibit the build up of amyloid protein in the brains of Alzheimer's disease patients.

This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months. CLICK HERE FOR MORE INFO

C5R sites participating in this study Contact Site Address Brenda Parks Study coordinator Tel: 780-735-8875 Fax: 780-735-6014 Glenrose Rehabilitation Hospital Dr Angela Juby Principal Investigator Regional Specialized Geriatric Program 10230 111th Ave., Rm 0427 Edmonton, AB T5T 5Y3 Lisa McAvoy Tel :613-544-3400 Ext: 3320 Fax: 613-542-9505 Dr. Angeles Garcia Principal Investigator Hotel Dieu Hospital 166 Brock Street, JM3, Rm 302 Kingston, ON K7L 5G2 Dr. Andrew Frank Tel: 613-562-6322 Fax: 613-562-6013 Memory Disorder Clinic Elisabeth Bruyere Health Centre 75 Bruyere St, Rm 216Y Ottawa ON K1N 5C8 Vicki Giardino, CCRP Tel: 416-386-9761 Fax: 416-386-0458 Toronto Memory Program 1 Valleybrook Drive, Suite 400 Toronto, ON M3B 2S7 Behnaz Ghazanfari Tel: 416-603-5800 Ext: 3406 Fax: 416-603-5768 Toronto Western Hospital 399 Bathurst Street 5ww-room 423 Toronto, ON M5T 2S8 or Whitby Mental Health Centre 700 Gordon Street Building 2, Level 2, Memory Clinic Whitby, ON L1N 5S9 Marybelle Campbell Tel: 519-685-4292 Ext: 42367 Sarah Best Tel: 519-865-4292 Ext: 42567 Fax: 519-685-4558 Parkwood Hospital 801 Commissioners Road East London, ON N6C 5J1 Dr. Ziad Nasreddine Tel: 450-672-7766 Fax: 450-672-1442 Clinique Neuro Rive-Sud 4896 Blvd Taschereau, Suite 250 Greenfield Park, QC J4V 2J2

1.a

How Drugs Are Approved in Canada

It is the responsibility of the Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB), Health Canada, to ensure that all drugs used by the public are safe and effective for specific conditions, and of high quality. This responsibility includes ensuring that drug manufacturers have tested the drugs they wish to market and that the public is protected during each stage of the drug's development.

Before being approved, a drug for the treatment of Alzheimer’s disease must be tested by the manufacturer according to strict procedures. Even if a drug receives approval for use in Canada, the monitoring of its effectiveness and side effects continues. For example, some side effects can be uncommon and do not show up during clinical trials, but are found once the drug is marketed and given to a greater number of people. The average time between initial laboratory work and marketing of a drug is 12 years. The following outlines the various steps involved in developing a drug:

Chemical and Biological Research
Laboratory tests are carried out in tissue cultures and with a variety of small animals to determine the effects of the drug. If the results are promising, the manufacturer will proceed to the next step of development.

Pre-Clinical Development
The drug is given to animals in various amounts and over different periods of time. If it can be shown that the drug causes no serious or unexpected harm at the doses required to have an effect, the manufacturer will proceed to clinical trials.

Clinical Trials -- Phase 1
The objective of Phase 1, the first administration in humans, is to test if people can tolerate the drug. If this testing is to take place in Canada, the manufacturer must prepare a Clinical Trial Application for the TPD. This includes the results of the first two steps and a proposal for the testing in humans. If the information is sufficient, the HPFB grants permission to start testing the drug, generally first on healthy volunteers. These trials typically consist of single doses given at one time, under carefully monitored conditions. This testing starts the process of identifying common side effects, as well as the dose range that can be tolerated.

Clinical Trials -- Phase 2
Phase 2 trials are carried out on people with Alzheimer’s disease, who are usually otherwise healthy, with no other medical condition. Trials carried out in Canada must be approved by the TPD. In Phase 2, the objective of the trials is to continue to gather information on the safety of the drug and begin to determine its effectiveness. Trials are designed and carried out by highly qualified investigators with expertise in Alzheimer’s disease. The drug is given for sufficient time to determine if it makes a difference, compared to people who are given another type of treatment. Side effects are identified and effective drug doses are determined.

Clinical Trials -- Phase 3
If the results from Phase 2 show promise, the drug manufacturer provides an updated Clinical Trial Application to the TPD for any Phase 3 trials, which will include Canadian sites. Many more people with Alzheimer’s disease will be involved, including those who have other medical conditions and those who are taking other medications. The objectives of Phase 3 include determining whether the drug can be shown to be effective, and have an acceptable side effect profile, in people who better represent the general population. Further information will also be obtained on how the drug should be used, the optimal dosage regimen and the possible side effects.

New Drug Submission
If the results from Phase 3 continue to be favourable, the drug manufacturer can submit a New Drug Submission (NDS) to the TPD. A drug manufacturer can submit a NDS regardless of whether the clinical trials were carried out in Canada. The TPD reviews all the information gathered during the development of the drug and assesses the risks and benefits of the drug. If it is judged that, for a specific patient population and specific conditions of use, the benefits of the drug outweigh the known risks, the HPFB will approve the drug by issuing a Notice of Compliance. The HPFB will also review and edit the Product Monograph submitted by the manufacturer. This document helps to ensure that the drug is used properly by providing physicians with the information they need.

For conditions that are life-threatening or cause severe impairment (such as Alzheimer’s disease), the HPFB can authorize a drug manufacturer to market a drug with the condition that the drug manufacturer undertake additional studies to verify the drug's benefit. This authorization is a Notice of Compliance with condition (NOC/c). A NOC/c is given to an eligible drug which has demonstrated promising clinical effectiveness in clinical trials. The product must be of high quality and possess an acceptable benefit. The conditions include a requirement to closely monitor the drug for adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation is removed.