Opportunities for Research into New Pharmaceutical Interventions

A great deal more is known about AD and dementia than previously, but new found knowledge and new drugs currently being studies also pose new questions. The following sections are some opportunities of research for AD.

§   Cholinergic therapies only bring about a temporary relief in AD symptoms, and it is not possible to predict who will respond. It is also unclear whether patients who do not respond to one anticholinesterase inhibitor will respond to another. Systematic clinical research is needed to answer these clinical questions. Furthermore, ways of measuring, determining response, and assessing when medications need to be stopped remain unclear and need to be addressed.[i] 

§   There may also be a need for more comparative clinical trials of these agents to determine which agent offers the greatest benefit and causes least resistance. The effective and appropriate administration of cholinergic and other medicines requires good baseline assessment with validated scales for objective measurement. Further work is required and practice guidelines are needed to assist clinicians in effectively diagnosing patients suspected with AD. There is also a need for better scales for the non-cognitive symptoms.^19,20

§   Cholinesterase inhibitors are licensed for use in mild to moderate AD and at present, there is insufficient data on their safety and efficacy in severe AD. Further studies are required to assess this.20^,38

§   More comparative trials evaluating multiple cholinergic medicines, as well as combination therapy with different classes for drugs, also remains unanswered and well-designed RCTs, with clear indications for appropriate doses for various stages of AD are needed.20

§   Additional well-designed studies, adequately powered, are needed to assess the beneficial properties of anti-inflammatory compounds such as ginkgo biloba, ibuprofen, and cerebrolysin.20

§   Studies are also needed to compare and assess different formulations and doses of vitamin E in altering the course of AD.20

§   Research recommendations for management of non-cognitive behavioural disturbances:

§   There is a need for more randomized clinical trials on the pharmacological treatment of anxiety, disinhibition, compulsive behaviors, wandering, agitation, and sleep disturbances associated with AD. Studies are required to assess which behavioural disturbance are best treated with pharmacological and non-pharmacological therapies. Furthermore, comparative studies are needed comparing anxiolytic, tri-cyclic antidepressants, SSRIs and novel antipsychotic medicines in AD.20

§   AD is a complex disease overlaid with neuro-psychotic and behavioural symptoms, and management rarely responds to medicines alone. Important factors other than cognitive functions and activities of daily living need to be studied. Behavioural modification and education combined with drug therapies as well as caregiver’s interventions require systematic clinical research. This will include time to institutionalization, quality of life issues as well as economic evaluations.20^,38

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[i] http://www.alz.co.uk/alzheimers/treatment.html. Alzheimer’s Disease International. Bullock R. Drug Treatments in Alzheimer’s Disease. Fact sheet 8. Revised April 2000. Last accessed April 1, 2004.