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1 Aging Clinical and Experimental Research Pharmacological treatment of Alzheimer s Disease* Angelo Bianchetti 1, Piera Ranieri 1, Alessandro Margiotta 1, and Marco Trabucchi 2 1 Department of Medicine, S. Anna Hospital, Brescia, 2 Geriatric Research Group, Brescia, Italy ABSTRACT. Background and aims: The treatment of Alzheimer s disease (AD) is a challenge for physician, families, and patients. An individualized, multimodal treatment plan addressing the treatment of cognitive, behavioural and functional decline is essential. Aim of the paper is to describe the principal components of the treatment plan of AD patients. Methods: A review of the recent literature was performed. Results: Acetylcholinesterase inhibitors (AChEIs) play an important role in the improvement of cognitive decline in mild to moderate AD, even if the improvement is not permanent. Data obtained from the CRONOS project (involving about 500 Alzheimer Evaluation Units) replicate in the real world those obtained in controlled trials, confirming that AD patients may benefit from AChEI treatment. Treatment of behavioral and psychological symptoms of dementia (BPSD) requires education of caregivers, non pharmacological interventions, identification and treatment of medical illnesses or environmental precipitating conditions, specific pharmacological treatment. Traditional neuroleptics are widely used for BPSD treatment, but limited data support their use, and side-effects are frequent and severe. Atypical antipsychotics are effective in treating BPSD, and safer than traditional neuroleptics. However, the increased risk of cerebrovascular accident in patients taking risperidone or olanzapine limited currently their use in demented subjects. The use of antidepressant drugs, as well as behavioral approach, may improve depressive symptoms frequently accompanying AD. Conclusions: Although at present there is no cure for AD, several drug treatments and care strategies may improve or stabilize cognitive and behavioral symptoms, and improve the quality of life of patients and families. (Aging Clin Exp Res 2006; 18: ) INTRODUCTION Pathways towards and away from Alzheimer's disease : this could be the title for a review on prevention and treatment of the silent epidemic of our times (1). In fact, although no current therapy can reverse the progressive cognitive and functional decline in Alzheimer s Disease (AD), several pharmacological substances and psychosocial techniques have been proven to be effective in reducing risk, slowing cognitive and functional decline, controlling behavioral symptoms, and improving quality of life of patients and caregivers (Table 1). Patients with dementia require an individualized, multimodal treatment plan: evolving with the progression of the illness, this can meet newly emerging issues, address the treatment of cognitive deficit and behavioral and psychological symptoms (BPSD), improve management of general medical conditions and complications, and enhance the education and counselling of caregivers and families. COGNITIVE DETERIORATION AS A PRIMARY OUTCOME OF TREATMENT Nowadays, strategies for primary therapy of AD are substantially limited to drugs improving central cholinergic neurotransmission, although a number of different drugs are under evaluation. The acetylcholinesterase inhibitors (AChEIs) are the most frequently used class of drugs for treating AD. Currently, second-generation AChEIs donepezil, galantamine and rivastigmine are marketed in Europe to treat the cognitive symptoms of mild to moderate AD. Daily treatment with donepezil is effective in the dose range 5 to 10 mg; rivastigmine in the range 6 to 12 mg; and galantamine in the range 16 to 24 mg. With some variability across studies, approximately twice as many patients who received active AChEIs had a four-point improvement on the ADAS- Cog with respect to patients receiving placebo (25-50% vs 15-25%), and approximately three times as many patients receiving AChEIs had a seven-point im- *This work was presented at the International Meeting - The Aging People, Pavia, 2-4 September Key words: Acetylcholinesterase inhibitors, Alzheimer s disease treatment, multidimensional approach, psychotropic drugs. Correspondence: A. Bianchetti, MD, Dept. of Medicine, S. Anna Hospital, via del Franzone 31, Brescia, Italy. angelo.bianchetti@grg-bs.it Received October 21, 2004; accepted in revised form May 30, Aging Clin Exp Res, Vol. 18, No. 2
2 Aging Clin Exp Res 18: , 2006 Alzheimer s disease treatment Table 1 - Proposed treatment options in Alzheimer s Disease. Outcome Treatment Prevention (or risk reduction) Antioxidants β-amyloid antagonists (secretase inhibitors, anti-aggregation compounds, amyloid vaccines) Anti-neurofibrillar drugs Genetic engineering Lipid-modifying agents (statins) Antihypertensive drugs Exercise Cognitive stimulation Delaying conversion MCI in AD Cholinesterase inhibitors Antioxidants (Ginko; Vitamin E) Improving symptoms Cholinesterase inhibitors Memantine Psychotropic drugs for behavior (antidepressants, atypical antipsychotics, anxiolytics, mood stabilizers, cholinesterase inhibitors) Cognitive rehabilitation techniques (reality orientation therapy, memory training) Behavioral management Family counselling and support Slowing progression Anti-oxidants (Ginko; Vitamin E) Hormones (estrogen) Neuroprotective agents (NGF) Reducing vascular risk (statins, homocysteine reduction) provement (12-20% vs 2-6% among those taking placebo) (2). All three drugs have a low incidence of serious reactions, commonly limited to cholinergic side-effects such as nausea, anorexia, vomiting and diarrhoea, as well as weight loss, insomnia, abnormal dreams, muscle cramps, bradycardia, syncope and fatigue. These drugs have similar cognitive efficacy (3). Some studies suggest that AChEIs improve cognition even in patients in more advanced phases of Alzheimer s Disease, and recent data indicate that donepezil is useful in reducing cognitive symptoms in mild cognitive impairment (4, 5). The improvement in cognitive or functional symptoms is not permanent, and the outcome of this treatment is a slowing in the progression of AD, corresponding to 8-12 months of the natural history of the disease. Studies also demonstrate that they may reduce the emergence of new behavioral disturbances and the need of institutionalization of AD patients, indicating a positive economic outcome (6, 7). The optimal duration of treatment with AChEIs is uncertain. Studies in which the rate of deterioration in the placebo group was extrapolated and compared with the level of function of patients continuing treatment suggest that patients continue to derive benefit from therapy for 2-3 years (2). Memantine, an N-methyl-D-aspartate antagonist, has recently been approved for treating moderate to severe AD (8). Placebo-controlled studies show the usefulness of memantine (alone, or in combination with AChEIs) in improving cognitive deficits and slowing functional deterioration in patients with moderate to severe AD. Clinical trials of other agents to improve cognitive function in AD are ongoing. These include estrogens, nonsteroidal anti-inflammatory agents, and botanic agents. The results of large-scale clinical trials using antioxidants (vitamin E, selegiline) show decreased rates of functional decline compared with placebo (9). Several strategies for the development of diseasemodifying treatment are under investigation, including antiamyloid therapies, neuroprotective agents, neurotrophic factors, antioxidants, anti-inflammatory, heavy metal chelators, but at the present time there are insufficient data to permit recommendations with respect to agents other than AChEIs and vitamin E (2). In March 2002, a phase IIa clinical trial of AD vaccine was stopped when sub-acute meningo-encephalitis developed in 18/298 cases (6%); post-hoc analysis indicated that those patients who generated Aβ antibodies had a reduction in disease progression (10). Researchers are investigating a new vaccination strategy, using safer immunogenic Aβ homologous peptides. THE ITALIAN CRONOS PROJECT EXPERIENCE With the aim of standardizing prescriptions of AChEIs and of assessing their effects on defined outcomes (cognition, functional status, behavior) in non-selected subjects, in October 2000 the Italian government started a national project called CRONOS, involving about 500 Alzheimer Evaluation Units (AEUs) and embracing all health districts (11). The project, besides adopting a definite attitude toward the reimbursement of AchEIs, aimed at building up a nationwide network of centers with a homogenous level of diagnostic and therapeutic competence. Much effort was expended with good results, since renewed organization of centers was stimulated, with standardized protocols and a data-base collected by the Ministry of Health. At the end of the project (March 2003), about 40,000 mild to moderate AD patients had been recruited. This pattern of prescription is lower than expected, revealing insufficient attention to early detection of the disease. We collected data from the AEUs of a northern Italy city (Cremona) on 1362 AD patients in the mild-moderate stage of the disease (mean age 77.4±6.9 years; 73.9% females; mean years of education 5.4±2.7; mean disease duration 26.9±15.7 months). Mean MMSE values in patients starting treatment were 19.2±3.9 at baseline, Aging Clin Exp Res, Vol. 18, No
3 A. Bianchetti, P. Ranieri, A. Margiotta, et al. Aging Clin Exp Res 18: , ±4.5 after three months (p<0.05, two-tailed t-test for paired samples) and 18.9±4.9 after 9 months (not significant at two-tailed t-test for paired samples vs baseline). Table 2 lists the clinical characteristics of the sample and main outcomes. Data replicated in the real world those obtained in controlled clinical trials. This fact further confirmed that non-selected AD patients with mild to moderate cognitive decline, seldom enrolled in randomized clinical trials, may benefit from AchEI treatment. The specific role of drugs when compared with the positive effects exerted by the care given at AEUs remains to be clarified. In the near future, the AEU system will be in charge in data monitoring on the efficacy and risk ratio of atypical antipsychotics in dementia. MANAGEMENT OF BEHAVIORAL AND PSYCHOLOGICAL SYMPTOMS OF DEMENTIA (BPSD) Treatment of BPSD is often challenging, and requires education of family members/caregivers and good communication between all persons involved in patient care, in addition to standard pharmacological and non-pharmacological interventions. In general, non-pharmacological approaches are the first-line treatment for BPSD, but for moderate or severe symptoms, medication is clearly indicated. Treatment should first be directed at identifying precipitants or undiagnosed medical illnesses or environmental antecedents, which should be corrected or eliminated. Traditional neuroleptics are the most common psychotropic medication prescribed for BPSD, and even limited data support their use, burdened by a high frequency of side-effects (12). There are open-label studies, case reports and recent placebo-controlled studies suggesting that atypical antipsychotics (clozapine, riperidone, olanzapine, quetiapine) are effective in treating BPSD and safer than older drugs (13). However, currently, no atypical antipsychotic is licensed specifically for the treatment of behavioral disturbances in dementia. Clozapine is highly effective in treating psychosis in patients with Parkinson s disease, but data on the treatment of behavioral disturbances in AD are very limited (14). Clozapine has significant side-effects, including agranulocytosis (in the USA, the implementation of the national registry system has reduced mortality related to agranulocytosis from 15 to 3%), sedation, seizures, hypotension and weight gain, discouraging use in AD (15, 16). Significant evidence demonstrates the efficacy of risperidone in BPSD treatment, even at low dosages (1-2 mg/day) (17, 18). The side-effects of risperidone include insomnia, hypotension, weight gain, and extrapyramidal symptoms (particularly for dosages greater than 6 mg/day) (16). Studies indicate that olanzapine is effective in BPSD, at dosages ranging from 1.25 mg to 5 mg/day (19). Common side-effects of olanzapine include sedation, orthostatic hypotension, seizures and weight gain. Olanzapine may increase motor symptoms in Parkinson s disease and worsen glycemic control in diabetic patients (16). Quetiapine has been shown to improve BPSD and be safe in AD, but available data are limited (20). Quetiapine should be initiated at a dosage of 12.5 mg at bedtime and titrated every five days until the desired effect is achieved (dosages range from 25 to 200 mg/day). Common side-effects include sedation, headache and orthostatic hypotension. In March 2004, after analyzing data from randomized placebo-controlled clinical trials and finding an increased risk of cerebrovascular adverse events in patients taking risperidone or olanzapine compared with placebo (OR 2.9 and 4.8 respectively), the regulatory agencies of some countries recommended that these two drugs should not be used to treat behavioral symptoms of dementia. In spite of this information, recent data demonstrate that the use of traditional neuroleptics in treating BPDS is associated with a greater risk of cerebrovascular accidents than that of atypical antipsychotics (21). AD patients with depressive symptoms should be considered for treatment, although they do not meet the classic nosographic criteria for depressive symptoms. Behavioral approaches (psychotherapy, activity groups, exercise, pets) may be useful (22). When medical treatment is indicated, the choice of drugs should be based on the patient s general medical condition and co-existing behavioral symptoms. Low doses of serotonin re-uptake inhibitors (particularly sertraline and citalopram) are the Table 2 - Clinical characteristics at baseline of 1362 patients enrolled in Piano Alzheimer project in Cremona (Northern Italy). Age (years) 77.4±6.9 [48-95] Sex (% female) 73.9 Education (years) 5.4±2.7 [0-21] Disease duration (months) 26.9±15.7 [5-96] Co-occurrent chronic diseases [0-4] None (%) or more (%) 59.0 MMSE score at baseline 19.2±3.9 [10-26] ADL (preserved) 4.8±1.5 [0-6] IADL (preserved) 3.8±2.6 [0-8] Previous use of AChEIs (%) 38.6 Delta MMSE after 9 months of treatment* <0 37.0% % % 4 or more 13.8% *Delta MMSE indicates improvement in MMSE score; level <0 indicates proportion of subjects whose scores worsened. 160 Aging Clin Exp Res, Vol. 18, No. 2
4 Aging Clin Exp Res 18: , 2006 Alzheimer s disease treatment most appropriate first-line agents (23). Combined serotonin- and noradrenergic re-uptake inhibitors are commonly used as second-line agents (24). Tricyclic antidepressants are effective treating depression, but have significant anticholinergic activity (especially amitriptyline, imipramine and clorimipramine) and should be used with caution in dementia (25). In the management of BPSD, non-pharmacological interventions may play an important role. Our group recently demonstrated that, in a protected environment (i.e., a rehabilitative ward specifically devoted to the treatment of severely demented subjects), NPI scores in a large group of patients could be significantly reduced, even after reducing the proportion of subjects treated with atypical neuroleptics. This preliminary observation further strengthens the need for a differentiated approach to BPSD, involving drug treatment but also giving attention to clinical, psychological and environmental stressors (26). CONCLUSIONS Although at present there is no cure for Alzheimer s disease, several drug treatments and care strategies may improve or stabilize cognitive and behavioral symptoms, and improve the quality of life of patients and families. Several agents that can slow the progression of the disease or delay its onset (such as growth factors, antiamyloid therapies, neuroprotective strategies, antioxidants, vaccination) are in development and clinical testing but, for the moment, the outcome of treatment is restricted to slowed cognitive and functional decline and improved BPSD (27). Optimal treatment of demented patients needs a comprehensive approach, specific programs and services. Among the pharmacological approaches to AD, a peculiar role must be given to the treatment of somatic diseases. In the early stages of AD, the control of diseases such as hypertension, diabetes and other chronic medical conditions may influence the clinical presentation of the symptoms of dementia; cognitive deficits also have an effect on awareness of symptoms and on compliance with treatment (28). As AD progresses, various conditions develop which may lead to death, such as pneumonia and upper respiratory infections, nutritional disorders, pressure sores, fractures and wounds. Management of these conditions in severely demented subjects induces significant clinical and ethical dilemmas (29). A clear definition of realistic outcomes of treatment, regular follow-ups using standardized measures to detect efficacy of treatment, and support and counselling of caregivers are essential for both clinical and health policy purposes. The results of studies conducted in the real world demonstrate that the improved quality of life of demented patients and their families is a reasonable outcome of treatment (7). REFERENCES 1. Mattson MP. Pathways towards and away from Alzheimer's disease. Nature 2004; 430: Cummings JL. Alzheimer s disease. N Engl J Med 2004; 351: Ritchie CW, Ames D, Clayton T, Lai R. Meta-analysis of randomized trials of the efficacy and safety of donepezil, galantamine, and rivastigmine for the treatment of Alzheimer Disease. Am J Geriatr Psychiatry 2004; 12: Bullock R, Hammond G. Realistic expectations. The management of severe Alzheimer Disease. Alzheimer Dis Assoc Disord 2003; 17: S Salloway S, Ferris S, Kluger A, et al. Donepezil 401 Study Group. Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. Neurology 2004; 63: Trinh NH, Hoblyn J, Mohanty S, Yaffe K. 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A randomized, placebo-controlled dose-comparison trial of haloperidol for psychosis and disruptive behaviors in Alzheimer's disease. Am J Psychiatry 1998; 155: Lee PE, Gill SS, Freedman M, Bronskill SE, Hillmer MP, Rochon PA. Atypical antipsychotic drugs in the treatment of behavioural and psychological symptoms of dementia: systematic review. BMJ 2004; 329: Hoeh N, Gyulai L, Weintraub D, Streim J. Pharmacologic management of psychosis in the elderly: a critical review. J Geriatr Psychiatry Neurol 2003; 16: Honigfeld G, Arellano F, Sethi J, Bianchini A, Schein J. Reducing clozapine-related morbidity and mortality: 5 years of experience with the Clozaril National Registry. J Clin Psychiatry 1998; 59: Motsinger CD, Perron GA, Lacy TJ. Use of atypical antipsychotic drugs in patients with dementia. Am Fam Physician 2003; 67: Rabinowitz J, Katz IR, De Deyn PP, Brodaty H, Greenspan A, Davidson M. 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5 A. Bianchetti, P. Ranieri, A. Margiotta, et al. Aging Clin Exp Res 18: , Street JS, Clark WS, Gannon KS, et al. Olanzapine treatment of psychotic and behavioral symptoms in patients with Alzheimer disease in nursing care facilities: a double-blind, randomized, placebo-controlled trial. The HGEU Study Group. Arch Gen Psychiatry 2000; 57: Fujikawa T, Takahashi T, Kinoshita A, et al. Quetiapine treatment for behavioral and psychological symptoms in patients with senile dementia of Alzheimer type. Neuropsychobiology 2004; 49: Herrmann N, Mamdani M, Lanctôt KL. Atypical antipsychotics and risk of cerebrovascular accidents. Am J Psychiatry 2004; 161: Teri L. Behavioral treatment of depression in patients with dementia. Alzh Dis Assoc Disord 1994; 8: Lyketsos CG, Lee HB. Diagnosis and treatment of depression in Alzheimer s Disease. A practical update for the clinician. Dement Geriatr Cogn Disord 2004; 17: Alexopoulos GC, Katz IR, Reynolds CF, Carpenter D, Docherty JP: Pharmacotherapy of depressive disorders in older patients. A Postgraduate Medicine Special Report. Minneapolis, Minn: Mc- Graw Hill, Cummings JL. Alzheimer s Disease. N Engl J Med 2004; 351: Bianchetti A, Trabucchi M. Behavioural and psychological symptoms of dementia: clinical aspects. Neurosci Res Commun 2004; 35: Bianchetti A, Trabucchi M. Clinical aspects of Alzheimer's disease. Aging Clin Exp Res 2001; 13: Bianchetti A, Frisoni GB, Trabucchi M. Do old age psychiatrists miss physical illnesses? Int J Geriatr Psychiatry 1993; 8: Rozzini R, Sabatini T, Trabucchi M. Medical treatment of acute illnesses in end-stage dementia. Arch Intern Med 2003; 163: Aging Clin Exp Res, Vol. 18, No. 2
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