Olanzapine in the prevention of psychosis among nursing home patients with behavioral disturbances associated with Alzheimer's disease

Poster Presentution: CAN (11011

WE

Drug Studies II

TRUST

S241

META-ANALYSIS

GALANTAMINE ALLEVIATES CAREGIVER BURDEN IN ALZ111031 HEIMER’S DISEASE: A C-MONTH PLACEBO-CONTROLLED

IN DEMENTIA?

STUDY Gordon

K Wilcock,

Clin Research, Intro Meta-analyses

are beginning

to be used in dementia

treatment and guide future research. Cochrane to he of higher medicine trials

quality

than other m&-analyses.

that results of meta-analyw

may

not agree.

Meta-analyaer reviewed

of

for

exclusions,

Reliability

of

from

Dementta

potential

We

Alzheimer’s

grouped

data and large single

in dementia

is unknown.

(Cochrane

Library.1999)

Group

bias.

ObJectives:

from other areas of

abstracted

relevant

data

trial design, patient types, outcome measures, interventions

Res. All

reviews

treatment

effect.

contained

sources of potential

In the few reviews

trial results, the review treatment

derived

effect or for ideniifying

produced rub-optimal

where there was homogeneity

did not add reliable

information

study

magnitude

of the individual

analyses. The greatest sowce of bias wac from the exclusion

included

pooling

studies

measures, combining

with

heterogeneous

studies with different

resulta,

ago but

still

Other

pooling

patient populations

trials that were not randomised,

long

pooled.

direction

of treatment known.

individual

patient

grouped known.

effect._None

The

only

meta-analysis

data meta-analyses

found

different

outcome

and different

treatment

critically

appraised,

wth

fcaturea, irrespective

ALL

of

results.

of whether

given

with

Therefore,

an

results

a narrative

systematic

review

trials and meta-analyses

to quality

THERAPY

of

to what is already

are

and size and other

they are capable of being statistically

REPLACEMENT

ALZHEIMER’S

review

or add little

relevant

wright

added to what was

a Cochrane

conflicting

available

appropriate

ESTROGEN

meta-analyses

data are not available,

in which

and Canada wth

tamine 24 or 32 mg/day,

FOR

Kevin

WITH

DISEASE

Ctr for Axed.

Bmton.

We performed women

with

Domingm,

a prospective Alrheimer’s

matched

Mm-Mental

for

(1 mg daily)

State Exam.

Rating

improvement).

of

(i.e., vaginal spotting).

in

whether

therapy

Dementia

(with

lower

the outcome Despite

with

with

months,

for

patients,

time

scale 0, i

did 0,

0.04,

from

higher

patients

who

patient7 with daily functioning

The total DAD

bawline

minutes). Conclusions: alleviate\

As well as producing

coregiver

score for or

At the end of 6 placebo

increased

In contrast the daily was maintained

time

needed

at

to assist

at 6 months by approximately

23 mmutes @ < 0.05). whereas patients in both galantamine (15-38

vs.

to a statisttcally

galantamine the daily

increased significantly

months.

compared

scale (p < 0.001

who received

group,

6

than placebo at 6 months on

vs. baseline).

received

in the placebo

At

function

dose vs. placebo).

2 hours @ < 0.001 patients

Moreover,

were assessed using

Results:

on the ADAS-cog

was more effective

spent supervising

to supervise

levels.

scale.

Impres-

burden was measured

better cognitive

not decrease

=

by approximately

required

baseline

to galan-

Disease Assessment

of daily living

(DAD)

0.05 for both doses vs. placebo).

extent

time

In a

patients from

Interview-Based

Caregiver

and activities

Dementia

as measured

patients

the dally

significantly

the Alzheimer’s

patients showed significantly

significant

Method:

trial,653

were randomized

and the Clinician’s

Input (CIBlC-plus).

placebo for both doses). Calantamine

clinically

receptors and

The aim of this study was

extend to caregivers.

variables included

time questionnaire,

placebo-treated

acetylcholine

severe AD

Assessment

galantamine-treated

nicotinic

acetylcholinesterase.

mild-to-moderately

plus Caregiver

Disability

modulates

Galantamine

groups required less tune

cognitive

and functional

benefits.

burden.

OLANZAPINE IN 11104) NURSING HOME

THE

PREVENTION

PATIENTS

ASSOCIATED

WITH

WITH

OF PSYCHOSIS

AMONG

BEHAVIORAL

DISTUR-

ALZHEIMER’S

DISEASE

depreawe

symptoms

Rating

symptoms

of depressloo

contribute

to the beneficial

effect\

in women of ERT

and

asessed and the

mood.

significant

between Although

the beneficial

with AD.

(age adjusted) over time.

improvements

side effects were minimal

for enrollment

baseline

who was

by ERT

or their families

these results. our study highhghts

modifying

wa\

(ADA%)

by a neuropaychologist

taking ERT,

for

Scale

scores on both exams indicating

measures differed

at

of evaluating

in

Four

residents with

to treatment

amall numbers.

In participants

(ERT)

facility.

Four additional

Re~ponw

of either the panlcipants

the importance

needed to confirm

of patient\

Rehuhilitutron

care (LTC)

Scale for Cognition

We found practical difficulties

based on unwillingness

Outcomes

the

tests were administered

in mood were found with ERT.

differences

with

Aaessment

Recults are shown on table below.

underscores

Hebrew

status. A repeated measures analysis of covariance

was used to determine

The

for 6 months.

served as controls.

Disease

Follow-up

m a long term

dementia

Scale ior Depression

blind to treatment

Lipsitz.

pdot study of estrogen replacement

disease IAD)

severity

using the Alrheimer’s Hamilton

Lewis

CNS

MA

residents received estradiol AD.

Dan K Kirly.

Lilienfeld,

escalated over 3-4 weeks, or to placebo, for a total treatment

\ion of Change the

requirements

with institutionalization.

placebo-controlled

subscale (ADAS-cog)

BANCES Ruth Kundel,

Sean

correlated

of galantamine

Scale cognitive

gslantamine

pooled.

WOMEN

Kingdom:

Be&urn

parallel-group,

period of 6 months. Efficacy

galantamine-treated

and

which inhibits

the benefits

double-blind,

the CIBIC-plus

meta-

for AD,

whether

randomized,

trials completed

may be untrustworthy,

Where individual-patient

should be conducted

to establish

dementia

comparison

United

Beer-se

and the supervision

are highly

and competitively

ConclCochrane

of the Cochrane

available

reversibly

and not including

not published.

Brrstol

Fdn,

exhaustmn

disease (AD)

with a caregiver

of

sources of biar

analyses harbour SOUIC~S of bias that may affect the assessment of the magnitude

already

Caregiver

is a novel treatment

Europe

of

to use repeated measurement\

trials where data were not capable of bang

regimes, including

were

on

for assessing the size of the

responders. Inability

published

and analysed

Meth.

and analyvx.

bias for asserting

Hasp,

Research

about

by some

are considered

It is known,

of m&-analysis

the Cochrane

sources

to make decisions

meta-analyses

Frenchay

Janssen

in a LTC

facility

to consent to ERT. the

two

larger

groups

studies

mean

mean score

psychotic

symptom%

uith the NPVNH @day

of olanzapine

compared

to olanapine

hallucinations (7.4%)

had a favorable extrapyramidal

Baseline

3 months

6 months

Control

26.18 29.89

24.13 (-2.05) 25.49 (-4.4)*

I .71

Treatment

25.46 C-0.73) 27.99 (-1.9)

I .02 (-0.75) 3.98 (~3.25)

1.27 (-0.5) 2.23 (-5.0)**

#s in parentheses indicate change from baseline. P values for change in score over time for control vs treatment groups. “P 5 .65 **p 5 .04

appearance

nor delusions

of these psychotic

(?I= 155),

hallucinations safety profile

symptoms. for

sign\

treated

patientr

symptoms.

was determmed patients entering

there was a significantly

symptoms among placebo patients fewer

olanzapine-treated

(21.9%

III each symptom-subgroup

labs, and vital

that may benefit

Results Among (n=76),

to placebo

with

results suggest that olanzapine

of psychotic

to assess the appearance of symptoms

For the larger subset of patients without

significantly

compared

patirnta

assoaated

nursing home

either placebo or a fixed dose of 5, IO, or IS

patients @=.006).

at baseline

developed

and safety ol

disturbances

paa hoc among

or hallucinations

for up to 6 weeks of therapy.

greater increase in development

the efficacy

and behavioral

Onset of psychotic

wth

the study with neither hallucinations

antipsychotic

6 months

Methods

during treatment

in

3 months

7.23

wch

to determine

cymptoms

patients who did not yet have delusions

different

Baseline

psychotic

disease. This analysis was performed

Thew

in mood may

Hamilton

Alrheimer’s

Conclusions

on cognition.

score

wth

study was conducted

in treating

significantly

of treatment ADASc

A multicenter

arc

effects of ERT

Improvement

Aims

olanrapine

with

p=.O45).

of patients.

were not statistically olanrapine

compared

patients

Olanupme Change,

in

or clinically to placebo.

may be a safe and well-tolerated

Alzheimer’\

dementia

hy reducing

the