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Phosphatidylserine - June 3, 1995
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Cognitive decline in the elderly: a double-blind, placebo-controlled
multicenter study on efficacy of phosphatidylserine administration

This double-blind study assesses the therapeutic efficacy and the saf=
ety of
oral treatment with phosphatidylserine (BC-PS) vs placebo (300 mg/day=
 for 6
months) in a group of geriatric patients with cognitive impairment. A=
 total
of 494 elderly patients (age between 65 and 93 years), with moderate =
to
severe cognitive decline, according to the Mini Mental State Examinat=
ion and
Global Deterioration Scale, were recruited in 23 Geriatric or General
Medicine Units in Northeastern Italy. Sixty-nine patients dropped out=
 within
the 6-month trial period. Patients were examined just before starting
therapy, and 3 and 6 months thereafter. The efficacy of treatment com=
pared
to placebo was measured on the basis of changes occurring in behavior=
 and
cognitive performance using the Plutchik Geriatric Rating Scale and t=
he
Buschke Selective Reminding Test. Statistically significant improveme=
nts in
the phosphatidylserine-treated group compared to placebo were observe=
d both
in terms of behavioral and cognitive parameters. In addition, clinica=
l
evaluation and laboratory tests demonstrated that BC-PS was well tole=
rated.
These results are clinically important since the patients were
representative of the geriatric population commonly met in clinical
practice.Cenacchi T, Bertoldin T, Farina C, Fiori MG, Crepaldi G. Cog=
nitive
decline in the elderly: a double-blind, placebo-controlled multicente=
r study
on efficacy of phosphatidylserine administration. Aging (ITALY) 5:123=
-133; 1993.

Effects of phosphatidylserine in Alzheimer's disease

We studied 51 patients meeting clinical criteria for probable Alzheim=
er's
disease (AD). Patients were treated for 12 weeks with a formulation o=
f
bovine cortex phosphatidylserine (BC-PS, 100 mg t.i.d.) or placebo, a=
nd
those treated with the drug improved on several cognitive measures re=
lative
to those administered placebo. Differences between treatment groups w=
ere
most apparent among patients with less severe cognitive impairment. R=
esults
suggest that phosphatidylserine may be a promising candidate for stud=
y in
the early stages of AD.
Crook T, Petrie W, Wells C, Massari DC. Effects of phosphatidylserine=
 in
Alzheimer=D5s disease. Psychopharmacol Bull 28:61-66; 1992.

Pharmacological treatment with phosphatidyl serine of 40 ambulatory p=
atients
with senile dementia syndrome

Phosphatidyl serine was administered for 60 days to subjects sufferin=
g from
chronic cerebral decompensation, producing an improvement in mnesic a=
nd
neuropsychic symptomatology with positive effects even some time afte=
r
suspension of the drug.
Lombardi GF. Pharmacological treatment with phosphatidyl serine of 40
ambulatory patients with senile dementia syndrome. Minerva Med(ITALY)
80:599-602;1989

Effects of phosphatidylserine in age-associated memory impairment

We treated 149 patients meeting criteria for age-associated memory
impairment (AAMI) for 12 weeks with a formulation of phosphatidylseri=
ne (100
mg BC-PS tid) or placebo. Patients treated with the drug improved rel=
ative
to those treated with placebo on performance tests related to learnin=
g and
memory tasks of daily life. Analysis of clinical subgroups suggested =
that
persons within the sample who performed at a relatively low level pri=
or to
treatment were most likely to respond to BC-PS. Within this subgroup,=
 there
was improvement on both computerized and standard neuropsychological
performance tests, and also on clinical global ratings of improvement=
. The
results suggest that the compound may be a promising candidate for tr=
eating
memory loss in later life.Crook TH, Tinklenberg J, Yesavage J, et al.
Effects of phosphatidylserine in age-associated memory impairment. Ne=
urology
41:644-649; 1991.

Effects of phosphatidylserine therapy in geriatric patients with depr=
essive
disorders

The effects of phosphatidylserine (BC-PS) on cognitive, affective and
behavioural symptoms were studied in a group of 10 elderly women with
depressive disorders. Patients were treated with placebo for 15 days,
followed by BC-PS (300 mg/day) for 30 days. The Hamilton Rating Scale=
 for
Depression, Gottfries-Br.ANG.ane-Steen Rating Scale, Nurse=D5s Observ=
ation
Scale for Inpatient Evaluation and Buschke Selective Reminding Test w=
ere
administered before and after placebo and after BC-PS therapy, to mon=
itor
changes in depression, memory and general behaviour. At the same time=
, basal
plasma levels of noradrenaline, MHPG, DOPAC, HVA and 5-HIAA, and
GH/beta-endorphin/beta-lipotropin responses to clonidine stimulation =
were
measured. BC-PS induced consistent improvement of depressive symptoms=
,
memory and behaviour. No changes in amine metabolite levels or in hor=
monal
responses to alpha 2-adrenoceptor stimulation were observed.Maggioni =
M,
Picotti GB, Bondiolotti GP, et al. Effects of phosphatidylserine ther=
apy in
geriatric patients with depressive disorders. Acta Psychiatr Scand (D=
ENMARK)
81:265-270; 1990.

Preliminary evaluation of the effect of GABA and phosphatidylserine i=
n
epileptic patients

The effect of the combined administration of gamma-aminobutyric acid =
(GABA)
and phosphatidylserine was evaluated in a pilot study of 42 patients =
with
drug-resistant epilepsy. The group included patients with complex par=
tial
seizures, simple partial seizures and absence seizures. Patients with
complex partial seizures and simple partial seizures showed no signif=
icant
improvement, on the other hand, there was a remarkable decrease in ab=
sence
seizures, linearly related to the dose of GABA and phosphatidylserine=
. Side
effects occurred in 9 patients and were usually mild.Loeb C, Benassi =
E, Bo
GP, et al. Preliminary evaluation of the effect of GABA and
phosphatidylserine in epileptic patients. Epilepsy Res (NETHERLANDS)
1:209-212; 1987.

Double-blind randomized controlled study of phosphatidylserine in sen=
ile
demented patients

A double-blind randomized controlled study was conducted in 42 hospit=
alized
demented patients to evaluate the therapeutical effect of phosphatidy=
lserine
(BS-PS). Half of the patients received 3 X 100 mg of this product, an=
d the
other half a placebo of the same appearance. After a wash-out period,
prescription lasted for six weeks. To evaluate the patients, two dist=
inct
rating scales were used: the Crichton Scale and an original one (Peri=
 Scale)
designed in our geriatric unit (see Appendix). A circle crossing test=
 was
added. Out of the 35 patients who completed the trial, 18 had receive=
d
placebo and 17 BC-PS. The results indicated a trend toward improvemen=
t in
the BC-PS treated patients and an analysis of covariance showed a
significant (p less than 0.05) treatment effect on the Peri Scale. Th=
e
results at the end of the treatment period were compared with those o=
btained
three weeks later. Here again there was a statistically significant
difference in the Peri Scale results, indicating that modifications a=
re
drug-related. The behavioral improvement shown in this study is in ag=
reement
with experimental studies on aged animals.Delwaide PJ, Gyselynck-Mamb=
ourg
AM, Hurlet A, Ylieff M. Double-blind randomized controlled study of
phosphatidylserine in senile demented patients. Acta Neurol Scand (DE=
NMARK)
73:136-140; 1986.

Effects of phosphatidylserine on the neuroendocrine response to physi=
cal
stress in humans

The activity of brain cortex-derived phosphatidylserine (BC-PS) on th=
e
neuroendocrine and neurovegetative responses to physical stress was t=
ested
in 8 healthy men who underwent three experiments with a bicycle ergom=
eter.
According to a double-blind design, before starting the exercise, eac=
h
subject received intravenously, within 10 min, 50 or 75 mg of BC-PS o=
r a
volume-matched placebo diluted in 100 ml of saline. Blood samples wer=
e
collected before and after the exercise for plasma epinephrine (E),
norepinephrine (NE), dopamine (DA), adrenocorticotropin (ACTH), corti=
sol,
growth hormone (GH), prolactin (PRL) and glucose determinations. Bloo=
d
pressure and heart rate were also recorded. Physical stress induced a
clear-cut increase in plasma E, NE, ACTH, cortisol, GH and PRL, where=
as no
significant change was observed in plasma DA and glucose. Pretreatmen=
t with
both 50 and 75 mg BC-PS significantly blunted the ACTH and cortisol
responses to physical stress.Monteleone P, Beinat L,Tanzillo C, et al=
.
Effects of phosphatidylserine on the neuroendocrine response to physi=
cal
stress in humans. Neuroendocrinology 52:243-248; 1990.

Blunting by chronic phosphatidylserine administration of the stress-i=
nduced
activation of the hypothalamo-pituitary-adrenal axis in healthy men

The effect of chronic administration of phosphatidylserine derived fr=
om
brain cortex on the neuroendocrine responses to physical stress has b=
een
examined in a placebo-controlled study in 9 healthy men. Phosphatidyl=
serine
800 mg/d for 10 days significantly blunted the ACTH and cortisol resp=
onses
to physical exercise (P =3D 0.003 and P =3D 0.03, respectively), with=
out
affecting the rise in plasma GH and PRL. Physical exercise significan=
tly
increased the plasma lactate concentration both after placebo and
phosphatidylserine. The results suggest that chronic oral administrat=
ion of
phosphatidylserine may counteract stress-induced activation of the
hypothalamo-pituitary-adrenal axis in man.Monteleone P, Maj M, Beinat=
 L, et
al. Blunting by chronic phosphatidylserine administration of the
stress-induced activation of the hypothalamo-pituitary-adrenal axis i=
n
healthy men. Eur J Clin Pharmacol (GERMANY) 42:385-388; 1992.

Double-blind study with phosphatidylserine (PS) in Parkinsonian patie=
nts
with senile dementia of Alzheimer=D5s type (SDAT)

Experimental and clinical studies showed that Phosphatidylserine=D1sp=
ecial
preparation from cow=D5s brain by FIDIA, Abano Terme, Italy=D1is able=
 to
influence cerebral changes contributed to the symptoms of senile deme=
ntia of
Alzheimer=D5s type. The application of the computerized EEG method DY=
NAMIC
BRAIN MAPPING (HZI Research Center, Tarrytown, New York) is able to p=
roof
the therapeutic effect of Phosphatidylserine: the acceleration of a s=
lowed
EEG in Parkinsonian patients with SDAT. These reactions were seen pre=
vious
to the favourable clinical influence documented by the Sandoz Clinica=
l
Assessment Geriatric Scale (SCAG), which showed a significant amelior=
ation
in anxiety, motivation and affectivity by the verum drug. Acute and
long-term CEEG results=D1till 18 months=D1showed that the so-called T=
heta
anteriorisation can be reduced or even abolished, this is replaced by=
 Alpha
waves. Even in preclinical cerebral changes this method open the poss=
ibility
to show incipient alterations of the brain metabolism. Preliminary
therapeutic results leads to this and not proven hypothesis that prev=
ention
or retardation of cerebral ageing might be possible.Funfgeld EW, Bagg=
en M,
Nedwidek P, et al. Double-blind study with phosphatidylserine (PS) in
parkinsonian patients with senile dementia of Alzheimer=D5s type (SDA=
T). Prog
Clin Biol Res 317:1235-1246; 1989.

Double-blind cross-over study of phosphatidylserine vs. placebo in pa=
tients
with early dementia of the Alzheimer type

Thirty-three patients with mild primary degenerative dementia accordi=
ng to
DSM-III (MMS between 15 and 27) took part in a double-blind cross-ove=
r study
of phosphatidylserine (Fidia, 300 mg/d) versus placebo. Both treatmen=
t
phases lasted for 8 weeks with an 8 week washout phase in between and=
 a 4
week washout phase before treatment phase one. Clinical global improv=
ement
ratings showed significantly more patients improving under BC-PS than=
 under
placebo during treatment phase one. The improvement carried over to t=
he
following wash-out and treatment phases. There were no significant
improvements in GBS dementia rating scale, psychometric tests or
P300-latency. 16-channel EEG mapping findings indicated that the pati=
ents
initially showed higher power values in all frequency bands (except a=
lpha),
when compared to a younger, healthy control group. BC-PS reduced the =
higher
power values compared to placebo, shifting EEG power more towards the=
 normal
level.Engel RR, Satzger W, Gunther W, et al. Double-blind cross-over =
study
of phosphatidylserine vs. placebo in patients with early dementia of =
the
Alzheimer type. Eur Neuropsychopharmacol (NETHERLANDS) 2 :149-155; 19=
92.

Phosphatidylserine in elderly patients. An open trial

Thirty-five patients (19 males, 16 females) with prevalent involvemen=
t of
cognitive functions associated with behavioural changes, were treated=
 with
phosphatidylserine (300 mg daily) for a period of two months. The
therapeutic activity of the drug was evaluated through neuropsycholog=
ical
tests and behavioural rating scales. The results obtained encourage u=
s to
suggest phosphatidylserine as a possible useful tool in the treatment=
 of
mild and moderate deterioration of cognitive functions.Granata Q, DiM=
ichele
J. Phosphatidylserine in elderly patients. An open trial. Clin Trials=
 J
24:99-103; 1987.

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