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Cholinesterase inhibitors are indicated for the symptomatic treatment of mild-to-moderate Alzheimer's Disease because they slow the progression of the disease. Its efficacy and safety have been demonstrated in placebo-controlled trials for ut to one year. By now, non-pharmachological interventions are also available; Reality Orientation Therapy (ROT) is the only one clearly effective as a Cochrane Library review has shown. A recent meta-analysis concluded that the ROT could improve both the cognitive performances and the behavioural disturbances. So, the ROT is the best candidate to be included in the therapy of Alzheimer's Disease. Recent studies have shown that the association of ROT to drug therapy can benefit more cognition than colinesterase inhibitor alone.
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G GERONTOL 2004;52:408-411
Società Italiana di
Gerontologia e
Geriatria
PACINIeditore
ILMODELLO RIABILITATIVO
L’efficacia dell’associazione tra farmaci e Reality
Orientation Therapy
Effectiveness of the association of donepezil and Reality
Orientation Therapy
O. ZANETTI, M. CALABRIA, M. COTELLI
U.O. Alzheimer, Centro per la Memoria, IRCCS Centro “S. Giovanni di Dio – Fatebenefratelli”,
Brescia, Italy
Cholinesterase inhibitors are indicated for the symptomatic treatment of mild-
to-moderate Alzheimer’s Disease because they slow the progression of the dis-
ease. Its efficacy and safety have been demonstrated in placebo-controlled trials
for ut to one year.
By now, non-pharmachological interventions are also available; Reality Orien-
tation Therapy (ROT) is the only one clearly effective as a Cochrane Library re-
view has shown. A recent meta-analysis concluded that the ROT could improve
both the cognitive performances and the behavioural disturbances. So, the ROT
is the best candidate to be included in the therapy of Alzheimer’s Disease. Re-
cent studies have shown that the association of ROT to drug therapy can benefit
more cognition than colinesterase inhibitor alone.
Key words: Donepezil • ROT
La Malattia di Alzheimer (AD) è la più comune forma di demenza nel soggetto an-
ziano e rappresenta una condizione altamente invalidante, in continuo aumento
in tutto il mondo a causa del progressivo invecchiamento della popolazione.
I farmaci, in particolare gli inibitori delle colinesterasi, rappresentano un punto di
riferimento consolidato e permettono un temporaneo rallentamento della pro-
gressione della malattia 1. Un recente lavoro 2ne suggerisce l’applicazione anche
per la terapia dei disturbi comportamentali nell’Alzheimer.
La Terapia di Orientamento alla Realtà (Reality Orientation Therapy; ROT), nell’am-
bito degli interventi psicosociali rivolti alla persona, è la più diffusa terapia cogniti-
va ed è stata applicata con successo in pazienti con deterioramento cognitivo 3.
La metodologia della ROT è stata ideata da Folsom nel 1958, presso la Veterans Ad-
ministration (Topeka, Kansas), e successivamente sviluppata da Taulbee e Folsom
negli anni ’60 come tecnica specifica di riabilitazione per i pazienti confusi o con
deterioramento cognitivo. La ROT è finalizzata a riorientare il paziente rispetto a
sé, alla propria storia e all’ambiente circostante. La ROT si fonda in parte sulle teo-
rie cognitive, le quali si pongono l’obiettivo di modificare comportamenti mala-
dattativi e di migliorare il livello di autostima del paziente facendolo sentire anco-
ra partecipe di relazioni sociali significative e riducendone la tendenza all’isola-
mento.
Tramite ripetitive stimolazioni multimodali – verbali, visive, scritte, musicali – la
ROT si prefigge di rafforzare le informazioni di base del paziente rispetto alle coor-
ICorrispondenza: dott. Orazio Zanetti, U.O. Alzheimer, Centro per la Memoria, IRCCS, Centro “S.
Giovanni Dio”, FBF, via Pilastroni 4, 25125 Brescia, Italy - Tel. +39 030 3501358 - E-mail: oza-
netti@oh-fbf.it
L’EFFICACIA DELL’ASSOCIAZIONE TRA FARMACI E REALITY ORIENTATION THERAPY 409
dinate spazio-temporali ed alla storia personale. Il
livello di stimolazione deve essere modulato ri-
spetto alle risorse del paziente. Si distinguono due
modalità terapeutiche tra loro complementari:
ROT informale e ROT formale – o in classe. La ROT
informale prevede l’introduzione di facilitazioni
temporo-spaziali nell’ambiente di vita del paziente
(calendari, colori alle stanze, segnali chiaramente
interpretabili) e un processo di stimolazione conti-
nua che implica la partecipazione di operatori sa-
nitari e familiari, i quali durante i loro contatti col
paziente, nel corso delle 24 ore, forniscono ripetu-
te informazioni di riorientamento. Come interven-
to complementare alla ROT di 24 ore, è stato svi-
luppata una ROT formale, che consiste in sedute
giornaliere di 45 minuti, condotte in gruppi di 4-6
persone omogenee per grado di compromissione
cognitiva, durante le quali un operatore impiega
una metodologia di stimolazione standardizzata, fi-
nalizzata a riorientare il paziente rispetto alla pro-
pria vita personale, all’ambiente ed allo spazio.
I migliori candidati alla ROT sono i pazienti con de-
terioramento cognitivo lieve o lieve-moderato, pri-
vi di deficit sensoriali e disturbi comportamentali
che possano pregiudicare la partecipazione alle se-
dute riabilitative.
Nel corso degli ultimi 25 anni numerosi ricercatori
hanno valutato l’efficacia della ROT. Nel 19824una
rassegna della letteratura è giunta alla conclusione
che la ROT è in grado di migliorare l’orientamento
nonché la memoria per fatti personali, ma con
scarse ripercussioni sul piano funzionale. Pochi
studi 5hanno analizzato la persistenza dell’efficacia
della ROT dopo la sospensione del trattamento.
Generalmente si ritiene che il termine della stimo-
lazione sia seguito da una rapida perdita di quanto
appreso. Risultati migliori si ottengono inserendo
la ROT nel contesto di un programma di stimola-
zione multimodale e multidisciplinare. La ROT
può, per esempio, essere opportunamente associa-
ta ed integrata con altre tecniche, quali la Remini-
scenza e la Rimotivazione 6 7; oppure può essere in-
serita nel contesto della terapia occupazionale, af-
fiancata alla riabilitazione motoria 8.
Uno studio longitudinale controllato 3con pazienti
affetti da malattia di Alzheimer (Mini Mental Status
Examination – MMSE – tra 11 e 24/30), della dura-
ta di otto mesi ha dimostrato che i pazienti sotto-
posti a ROT presentavano un miglioramento delle
prestazioni cognitive al MMSE di 0,68 punti, men-
tre il gruppo di controllo presentava una perdita di
2,58 punti (Tab. I). La differenza tra i due gruppi ri-
maneva significativa anche dopo aver controllato,
in un’analisi multivariata, per le variabili potenzial-
mente confondenti (durata della malattia, depres-
sione, prestazioni cognitive alla baseline, età, gra-
do di autonomia, numero di malattie fisiche con-
comitanti). I dati suggeriscono che la ROT è in gra-
do di rallentare la progressione dei sintomi cogni-
tivi nel paziente con compromissione lieve-mode-
rata e senza rilevanti disturbi comportamentali.
Poiché il normale decorso consiste in un progres-
sivo declino cognitivo (la perdita attesa annuale
oscilla tra 1,8 e 4,2 punti al MMSE 9), il solo rallen-
tamento, e non necessariamente un miglioramen-
to, può essere considerato evidenza di efficacia.
La ROT si è dimostrata efficace anche nel ritardare
l’istituzionalizzazione di sei mesi nei pazienti AD di
grado lieve e medio 10.
A sancire definitivamente l’efficacia della ROT è
soprattutto la revisione della letteratura effettuata
dalla Cochrane Library 11. Una recente meta-analisi
curata da Spector e Orrel 12 è giunta alla conclusio-
ne, sulla base dell’esame di studi randomizzati con-
trollati, che la Reality Orientation Therapy è effica-
ce sia sulla cognitività (Fig. 1) sia sul piano com-
portamentale (Fig. 2). La ROT dovrebbe pertanto
far parte delle offerte terapeutiche rivolte al pa-
ziente con malattia di Alzheimer.
Quali siano i migliori candidati alla ROT è un inter-
rogativo ancora aperto. Secondo uno studio di Za-
netti et al. 13 la presenza di un deficit cognitivo mo-
Tab. I. Modificazioni dei parametri cognitivi, funzionali e affettivi nel gruppo sperimentale (sottoposto a ROT) e di controllo
nell’intervallo di osservazione (8 mesi).
MMSE ADL IADL GDS
Media SD Media SD Media SD Media SD
Gruppo sperimentale 0,68 + 2,44 - 0,44 + 0,63 - 1,31 + 1,96 - 0,31 + 5,11
Gruppo di controllo - 2,58 + 5,68 - 0,25 + 0,62 - 1,25 + 1,29 0,25 + 2,38
Effetto del trattamento
Media 3,27 - 0,19 - 0,06 - 0,56
95% CI 0,18 - 6,36 - 0,66 - 0,28 - 1,34 -1,21 - 3,69 - 2,56
O. ZANETTI, M. CALABRIA, M. COTELLI
410
derato, (anziché lieve) nonché l’assenza di disturbi
comportamentali della sfera frontale, si associano
ad una maggiore probabilità di efficacia della ROT.
Infine un recente studio multicentrico che ha coin-
volto circa 120 pazienti affetti da demenza, non so-
lo conferma l’efficacia della ROT, ma dimostra co-
me i risultati ottenuti con la ROT siano del tutto
comparabili a quelli dimostrati per gli anticoline-
sterasici; inoltre anche il Number Neede to Treat è
risultato assolutamente identico a quello dei farma-
ci ossia 7. Il lavoro concludeva auspicando l’utiliz-
zo abbinato di trattamento farmacologico e non
farmacologico 14.
In questa ottica si è recentemente concluso uno
studio italiano multicentrico randomizzato e con-
trollato finalizzato alla verifica dell’efficacia dell’as-
sociazione tra donepezil e ROT erogata al domici-
lio da un caregiver adeguatamente formato da
esperti in ROT. Lo studio, della durata di sei mesi,
ha coinvolto 156 pazienti affetti da AD di cui 70
trattati e 67 controlli.
Nel gruppo dei trattati è stato dimostrato un effetto
positivo del trattamento combinato – ROT associata
a donepezil – sia tramite l’ADAS-cog (p = ,005) che
il MMSE (p = ,01) rispetto al gruppo di controllo.
Un ulteriore studio 15 ha evidenziato una maggiore
efficacia dell’associazione tra inibitori delle coline-
sterasi e interventi riabilitativi individualizzati, del-
la durata di tre mesi, rispetto al solo trattamento
farmacologico.
Fig. 1. Meta-analisi degli studi rando-
mizzati controllati relativi alla ROT nei
quali è stata valutata l’efficacia sui de-
ficit cognitivi (adattata da Spector et
al., 2000 16).
Fig. 2. Meta-analisi degli studi randomizzati controllati relativi alla ROT nei quali è stata valutata l’efficacia sui disturbi com-
portamentali (adattata da Spector et al., 2000 16).
L’EFFICACIA DELL’ASSOCIAZIONE TRA FARMACI E REALITY ORIENTATION THERAPY 411
I farmaci, in particolare gli inibitori delle coline-
sterasi, rappresentano un punto di riferimento
consolidato per la Malattia di Alzheimer e per-
mettono un temporaneo rallentamento della sua
progressione. Oltre al trattamento farmacologi-
co, abbiamo a disposizione interventi riabilitativi
quali la Reality Orientation Terapy (ROT). A san-
cire definitivamente l’efficacia della ROT è so-
prattutto la revisione della letteratura effettuata
dalla Cochrane Library. Una recente meta-analisi
è giunta alla conclusione, sulla base dell’esame di
studi randomizzati controllati, che la Reality
Orientation Therapy è efficace sia sulla cogniti-
vità sia sul piano comportamentale.
In conclusione, la letteratura recente sembra sug-
gerire l’opportunità di affiancare alla terapia far-
macologica interventi di riabilitazione cognitiva.
Parole chiave: Donepezil • ROT
In conclusione, la letteratura recente sembra sug-
gerire l’opportunità di affiancare alla terapia farma-
cologica interventi di riabilitazione cognitiva. La
ROT dovrebbe pertanto far parte delle offerte tera-
peutiche rivolte al paziente con malattia di Alzhei-
mer.
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... At present, ROT is one of the most widely used rehabilitative strategies for patients with dementia, and at the same time, it represents one of the few examples of rehabili-tation which have shown positive effects in patients with Alzheimer's Disease (Zanetti et al., 1995). Our study aimed to evaluate the possibility of using Adapted Pet Therapy for formal ROT (Zanetti et al., 2004) with patients exhibiting a light to moderate level of Alzheimer's. The goal was to avoid, using the co-therapist animal, stagnation in the therapy program and to continue the multimodal stimulation, overcoming moments of resistance in the patient. ...
... Formal ROT: The Formal ROT intervention was carried out according to a standard protocol (Zanetti et al., 2004;Zanetti et al., 1995;Spector et al., 2001) on a weekly basis for 45 minutes over a period of six months. ...
... This goal can be achieved through two complementary modes of operation: formal ROT and informal ROT (or ROT in class). 9 The former consists of repeated stimulation of spatialtemporal reorientation during the course of the day, through interactions between the patient and health professionals or family members. Formal ROT involves a small group of patients (4-6 subjects), who are homogeneous in terms of cognitive impairment, who meet for about 45 min/day in a well-structured environment. ...
... 21,22 Formal ROT The formal ROT intervention was performed on a weekly basis according to the formal ROT protocol. 9,10,18 Sessions were 45 min, and they were held over a 6-month period. ...
... To this group a cycle of AAT interventions based on the protocol of formal ROT [11,12] was addressed. The ROT group comprised 31 patients (9 men, 22 women), engaged exclusively in activities of formal ROT [25][26][27]. Finally, 31 patients (10 men, 21 women) formed the CTRL group participating in no stimulations. ...
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