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Taken from http://www.thorne.com/phosphatidylserine.html Phosphatidylserine - June 3, 1995 ---------------------------------------------------------------------= --- 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. <Picture> Back to Thorne Abstract Listing=20 ---------------------------------------------------------------------= --- <Picture> Return to Thorne Research Home Page=20 ---------------------------------------------------------------------= ---