Diseño del Hardware para el sistema de control.

The effectiveness, even if modest, shown by the anticolinergic agents in the therapy is reproducible only in the clinical practice in presence of determined factors:

1. Sees the specificity of these medicines a diagnosis of Alzheimer’s disease is necessary, from at least six months, with exclusion of other causes of senile dementia (above all vascular causes), not to uselessly expose the patients to non appropriate therapies.

2. Once effected the diagnosis of Alzheimer’s disease, must be appraised that is in a precocious phase and that is of light-moderate degree, since the effectiveness of these colinergic drugs has only been made a will in this circle. To the purpose to notice the light-moderate disease’s degree is opportune at least to submit the patients to the MMSE test. A score among 10 and 24 is indicative of light-moderate Alzheimer. To confirmation of cognitive functions state of the patient, would be opportune to administer a further test besides, as for instance the ADAS-Cog.

3. In the choice of the medicine, since studies of comparison don't exist, it would be owed at least account of the exclusion criterions of patients in the effected clinical studies. For the donepezil they have been: diabetes insulin-dependent or other endocrine disorders, asthma, pulmonary obstructive troubles, troubles to load of the gastro-intestinal or cardiovascular line, hypersensitivity verified towards the colinesterasi inhibitors, anticolinergic drugs assumption, anti-spasms, antidepressants and antipsychotics. During the experimentation, also other active medicines on the

SNC had been abolished or limited in the use12. For the rivastigmina, in the studies of phase III, all the patients have been excluded with serious disease in progression and patients with indicative clinical data of the liver and renal deficit functionality. In the studies checked of phase III have been included patient however with concomitant pathologies as the hypertension. The administration of medicines that could influence the determination of the effectiveness has been forbidden, to exception of the hydrated “cloralio” in case of insomnia or occasional nervousness13. It’s worth stop on these restrictive criterions, above all as it regards in donepezil. If from a side it’s correct that restrictive criterions are used, for the correct carrying out of the checked clinical study, from the other one it needs to consider that is rather rare, in the clinical practice, to meet patient in advanced age without pathologies or concomitant treatments.

4. Should be considered the possibility to administer the colinergic drugs dosing more elevated, if born, since her totality of the clinical studies has almost shown a good effectiveness in to improve the cognitive troubles proper to the most elevated doses. 5. A precocious monitorating of drugs bearly must be effected, since above all to tall

doses the onset of collateral effects is had, such to ask for the suspension of the treatment. A first evaluation after two weeks of therapy can be made for verifying the appearance of collateral effects. The more communes both for the donepezil and for the rivastigmina are nausea, vomit and diarrhea. For the donepezil has been in relief insomnia, while for the rivastigmina anorexia. Particularly the rivastigmina has an

12 _{Birks, Melzer- Donezepil for mild and moderate Alzheimer’s disease - 1999} 13 _{Rivastigmine, European Public Assessment Report (EPAR), CPMP/243198 rev. 1}

elevated incidence of collateral effects, above all to tall doses, so much to be recorded percentages of abandonment of the studies around 30%.

6. If the drug is bear, must be perform some evaluations of the patient’s answer to brief and for a long time term, the first one should be effected to three months and the second to six months of therapy, again submitting the patient to the cognitive tests. 7. It is opportune to interrupt the treatment if there are problems of tolerance and

compliance, if a cognitive deterioration is recorded to the levels of pre-treatment or, straight, if is assisted to a worsening. The treatment can be maintained instead if an improvement or a stabilization is verified or also a deceleration of the disease progression.

8. It is important to hold under observation the patients besides, when they suspend the therapy, since cases of precipitous worsening of the insanity are brought. If this is verified in an observation’s arc of six weeks, following suspension of the pharmacological therapy, could be opportune to take back the treatment.

Considering that the greatest part of the studies till now effected has considered periods around the six months, the easiest strategy to cross it seems the evaluation of the patient cognitive state to regular intervals, deciding as soon as whether to continue or no the therapy. From how much said is understood as the correct use of such drugs implicates a diagnostic-therapeutic run anything else other than simple. In this motivation probably resides for which their prescription is reserved, according to the immission’s decree in commerce, to the "experienced experts in the management of Alzheimer’s disease."