Research Into Dementia

This page has information on:

• Introduction

• Clinical Trials

• Should you participate in clinical trials?

• Scientific Research

• How to become involved

Introduction

There are two basic areas of medical research into dementia:

• Clinical Trials - researching the treatment and management of dementia, involving the testing of drugs and therapies.
  

• Scientific Research - advancing our understanding of dementia, its causes, effects and diagnosis.

Back to top

Clinical Trials

Before a new drug or treatment can be made available to doctors, it must be thoroughly tested to ensure both that its use for a specific condition is effective and that it is safe.

A clinical trial or study is a test of a new drug in people prior to approval of the drug by the Medicines Control Agency (MCA) for general use. A trial may last weeks or months, during which time medical personel will monitor your condition to see whether the treatment is helping your symptoms. They will also check whether you are experiencing any side-effects.

A specialist may recommend a trial drug as the most appropriate treatment for a patient. Participation in a trial has both potential advantages and disadvantages. If the new drug works, trial patients have the opportunity to take it months, or even years, before it is widely available. For example, we have conducted trials for ARICEPT, EXELON, REMINYL and EBIXA, all of which have now been licensed. However, a trial drug may not provide any benefit and occasionally may cause unwelcome side effects.

How Clinical Trials Work

A pharmaceutical company must conduct extensive pre-clinical or laboratory research before it can initiate testing in humans. If this stage of testing is successful, a pharmaceutical company provides data to the regulatory authority (the Medicines Control Agency - MCA - in the UK) requesting approval to begin testing the drug in humans.

The clinical (human) testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the MCA has approved the drug for general use, then pharmaceutical companies also conduct post-marketing or late Phase III / Phase IV studies.

Phase I Studies

Phase I studies are primarily concerned with assessing a drug’s safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20-100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body - how it is absorbed, metabolised and excreted. A Phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70% of experimental drugs pass this initial phase of testing.

Phase II Studies

Once a drug has been shown to be safe, it must be tested for efficacy (how well it works). This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most Phase II studies are randomised trials. One group of patients will receive the experimental drug, while a second ‘control’ group will receive a standard treatment or placebo (dummy pill). Often these studies are ‘randomised and double-blinded’ - neither the patients or the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and regulatory authorities comparative information about the relative safety of the new drug and its effectiveness. Only about one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase III Studies

In a Phase III study, a drug is tested in several hundred to several thousand patients. This large scale testing provides the pharmaceutical company and regulatory authorities with a more thorough understanding of the drug’s effectiveness, benefits and the range of possible adverse reactions. Most Phase III studies are randomised and blinded trials.

Phase III studies typically last several years. 70% - 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once a Phase III study is successfully completed, a pharmaceutical company can request approval from the regulatory authority for marketing the drug.

Post Marketing - Late Phase III / Phase IV studies.

In late Phase III / Phase IV studies, pharmaceutical companies have several objectives:

• studies often compare a drug with other drugs already in the market
• studies are often designed to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life.
• many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

Back to top

Should you participate in clincal trials?

People participate in medical research for a variety of reasons. People who volunteer for Phase II and Phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the doctors during the course of the study. In the UK this treatment will always be free.

The patient’s rights and safety are protected in two important ways:

The study must obtain approval from an ethics committee in the UK

This can be an LREC (local regional ethics committee) or an MREC (multi-regional ethics committee) or sometimes both. The ethics committee, which is usually composed of doctors and lay people, examines the study’s protocol to ensure that patient’ rights are protected and that the study does not present an undue risk to the patient.

The patient and their carer are required to sign an ‘informed consent’ form

The form details the nature of the study, the risks involved, and what may happen to a patient in the study. The 'informed consent' tells the patient that they have the right to leave the study at any time.

Patients considering participating in medical research should talk about it with their GP and Specialist. Questions to ask include:

• What is the purpose of the research?
• Has the research been approved by a medical ethics committee?
• What does the research involve for the person with dementia?
• Will the patient benefit from participation?
• Will the patient be given injections or tablets?
• Will the patient have to undergo blood tests or other investigations?
• Will it involve discomfort?
• Will it cause distress or anxiety?
• Will there be any side-effects or risks and how serious could they be?
• Is the patient insured against any harm from taking part in the study?
• Will participation require extra visits to the hospital?
• Where would the patient have to attend and how often?
• How long will it go on?
• Might the patient be one of a group used for comparison who receive a ‘sugar pill’ (placebo) or no treatment?
• If the research involves treatment, can the patient continue with the treatment if it benefits them?
• Will the patient need to have further medical checks after the study ends?
• What will we be told after the research is completed?
• Will expenses be paid?
• Who can the patient or carer talk to if they have any questions or problems?

Back to top

Scientific Research

An individual who participates in scientific research will not themselves directly benefit from it. However, this kind of research is essential so that treatments and methods of prevention can be developed and others may benefit in the future. Healthy volunteers are often required for this type of research.

As with clinical trials, projects should obtain approval from and ethics committee in the UK to ensure that the patients rights are protected and that the research does not present undue risk to the patient.

Currently work is being done in three main areas:

• improving methods of diagnosing and monitoring the disease.
  
• identifying genes that may influence the development of dementia.
• examining the brain to identify what areas have been affected and how.

A person with dementia or a healthy volunteer may be asked to:

• take a number of psychological tests on a regular basis over a period of time.
• give blood for genotyping.
• consent to a post-mortem on the brain after death. (For further information on Brain tissue donations, you may wish to look at the Alzheimer's Society Information Sheet.)

Other areas of scientific research include:

• evaluation of how treatments affect the quality of life of the person with dementia and/or the carer.
• investigation of the impact of carer and patient support programmes and activities.
• health policy research, providing guidelines for the achievement of the best possible quality of care for people with dementia and those who care for them

Back to top

How to become involved

The Kingshill Research Centre conducts research into dementia (both clinical trials and scientific research ) in the Wiltshire area of the UK.

Any volunteers must be OVER 45 YEARS OLD and LIVE IN WILTSHIRE OR THE SURROUNDING AREA (please contact us if you are unsure whether you may be eligible to participate).

• We regularly conduct trials suitable for volunteers with probable dementia.
  
  
• We also run a memory clinic where people experiencing mild memory loss (which we call Mild Cognitive Impairment or MCI) can be monitored. Anyone attending memory clinic will be offered the opportunity to participate in drugs trials if they are appropriate to their condition.
  
  
• We sometimes run trials involving healthy volunteers. If you are OVER 45 YEARS OLD and LIVE IN WILTSHIRE we can place your details on our database and will contact you if a suitable project arises.

If you or your relative meet these criteria and wish to volunteer, please contact The Kingshill Research Centre - you can complete our On-line Research Enquiry Form or 'phone or write to us -see our Contact Page for details.

Back to top

Home | About Us | Site Map | Dementia Search | Contact
What is Dementia? | Where to get help | Dementia Research | Dementia Links & Resources | Dementia FAQs
Kingshill's Research | Facilities & Services | The Team | How to Find Us

Copyright © 1998, 1999, 2000, 2001, 2002, 2003, 2004 Kingshill Research Centre
(The Kingshill Research Fund - An Avon and Wiltshire Mental Health Partnership Charitable Fund, Registered Charity No. 1056576)
Avon and Wiltshire Mental Health Partnership NHS Trust:
Central Offices, Bath NHS House, Newbridge Hill, Bath, Somerset, BA1 3QE
e-mail:webmaster@kingshill-research.org
All rights reserved.
Site Policy Statements