P-8-12 nicergoline in the treatment of dementia the effects on cerebral blood flow measured by spect – docslide.com.br what is anoxic encephalopathy

P-8 aging, dementia and neurodegenerative diseases 383

Those that showed minlmal effects in a previous phase II study using a

Total daily dose of 6 mg (bid regimen). These results demonstrate that ENA

713 can be administered to AD patients in higher doses which may show

Greater potential for clinical efficacy ~n AD

Nicergoline in the long term treatment of mild or

Moderate senile dementia. A multicenter

Double-blind, randomized, placebo-controlled trial

A. Battagliat, K. Annonil . F. Pamparanal,C. DePaolisl , M.L bonural

W. Stekke 2, nieergoline dementia long term study italian group.

1 medical dept., pharmacia, mz/an, italy, 2 medical dept, pharmacia,

S.A,~ V, bruxe/les, belgium

One hundred and eight patients with a clinical history of cognitive function

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Decline lasting a minimum of 6 months and a d~agnosis of degenerative

(SDAT). Multi-infarct(MID) or mixed dementia according to DSM I11, NINCDS-

ADRDA criteria and hachinski ischemic score (HIS), were recruited in 5

Italian neurological centers and randomized to either oral nicergoline (nic)

Or placebo (PI) b.I.D, pp. For 12-month treatment under a double-blind

Parallel group design. All patients gave their informed consent

Fifty-nine males and 49 females, mean age 691 4- 6.3 years (range 55-81

Years) with mild to moderate dementia (global deterioration scale grade 2-

4) received nic 30 mg b id (54 cases) or PI (54 cases). Depressed patients

(hamilton rating scale for depression 18) were excluded.

Visits were scheduled every 3 months; efficacy was evaluated by the

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Sandoz clinical assessment geriatric (SCAG) scale at baseline and at each

Visit, by the mini mental state (MMS) examination at baseline and at 6 and

12 months, and by physician and patient global evaluation of treatment


Trial data were submitted to an intent to treat analysis; 101 patients

Completed the study period. Seven patients withdrew from the study (3 n

Nic group and 4 in PI group)

No significant differences between the groups were observed at baseline

For sex (nic: males 49%, females 51%; PI: males 60%, females 40%, age

(nic: 68.7 ± 6.1 years; PI: 69.8 4- 6.7 years), pathogenesis according to

HIS (nic: SDAT 33%, MID 47%, mixed forms 20%; PI SDAT 37%, MID

48%, mixed forms 15%), concomitant diseases, vital signs and neuropsy-

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Chological and clinical scores (total SCAG: nic: 491 4- 92; PI: 49 1 :I: 69

MMS: nic 21 3 4- 3.1 ; PI 21 1 4- 2.7). Progressive ~mprovement was seen

In nicergoline patients according to the SCAG (total score at 6 months 45.5

9: 0.4, at 12 months 45.4 4- 11.7L while target symptoms worsened in

Placebo patients (total scores at 6 months 501 4- 7.6, at 12 months 537 4-

10.2). This corresponded at 12 months to a man delta between nic and PI

Of 8.2 points (raw means). A simdar pattern was seen in MMS scores with

Nicergoline patients showing improvement or stabilization: (MMS score at

6 months 21.8 9: 42, at 12 months 21.2 9: 43) scores in the placebo group

Worsened: MMS at 6 months 20,1 9: 34. At 12 months 19.0 4- 40.What is anoxic encephalopathy for

Both SCAG (total score, as well as all clusters and global impression on the

Patient) and MMS a highly stgnificant difference :n favour of n~cergoline vs

Placebo was observed for raw data, as well as for changes from baseline

And for data adjusted for clinically relevant covar~ates

Twenty-seven (53%) patients given nic and 5 (10%) patients gwen PI were

Judged as improved or much improved by the ~nvest~gator, while 18 (35%)

And 29 (58%) respectively were iudged unchanged and 6 (12%) and 16

{32%) respectively were judged as worsened the patient assessment was

Very similar the difference was highly s~gnificant in favour of nicergoline in

Both physician and patient judgement

Five (9%) patients in the nic group and 4 (7%) in the PI group reported

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10 mild and transient adverse events, none of them was considered drug-

Related no clinically relevant changes in vital signs were observed

In this study, long term treatment w i thntcergo l ine30mgbid tnpat~ents

Suffering from mild to moderate senile dementia was shown to be safe a~ld


Nicergoline in the treatment of dementia: the

Effects on cerebral blood flow measured by SPECT

G fabbrinil, N. Mar tucc i l ,A battaglia2. E pamparana2, K. Annon~2.

1 /stituto neurotraumatologico/taliano, grottaferrata, rome, italy; 2 medical

Department, pharmacla, mdan, italy

The effects of drugs used in the therapy of multilnfarct dementia (MID) ano

Alzheimer’s disease dementia lad) are usually assessed in terms of efficacy

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On measures of cognitive function however, in bothad and MID. The 0at-

Terns of cerebral blood flow (CBF) changes are well established. Therefore

The effects of drugs on CBF may be used as an adjunctive measure of


In an attempt to clarify the mechanism of action of nicergoline, a drug

Which is widely used in the therapy of aging brain and dementia, we mea-

Sured CBF changes induced by the drug in 10 AD and 10 MID patients.

Severity of disease was rated mild to moderate (score from 3 to 5 on the

Global deterioration scale for dementia). After a 15-day washout from other

Centrally acting medications, patients underwent baseline cognitive testing

According to a multicenter study protocol. Brain MRI was performed on

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All patients at baseline. Patients were then randomly allocated, following a

Double blind design, to treatment either with nicergoline (nic), given orally

30 mg b.I.D., or placebo (PI) b.I.D, the treatment lasted six months and at

The end of the treatment period the patients underwent a final evaluation of

Cognitive efficiency.

Regional CBF was studied by using SPECT with 99tc-HM-PAO. The stud-

~es were conducted at baseline and at the end of the 6-month treatment

Course by means of a conventional gamma camera using a low energy

H~gh resolution parallel hole collimator, equipped with a computer sys-

Tem patients were studied while lying supine with closed eyes in a quiet

Room the hexamethylpropylene-amine-oxime (HM-PAO} freeze dried kit

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[ceretect: amersham international) was recomposed within ten minutes

Of preparation with 99tc-pertechnetate solution and injected in an antecu-

Bital vein. Acquisition of signal was started from 20 to 60 minutes after

Rejection. Axial slices were reconstructed by the filtered back projection.

Regional tracer uptake was assessed by a semiquantitative method: re-

Gional radioactivity count densities were obtained for four pairs of bilateral

Regions (frontal, temporal, parietal, occipital) and relative tracer activity was

Expressed as a ratio of the regional activity to mean counting over cerebellar


The results of the clinical study revealed a significant improvement in M ID

Patients treated with nic: SCAG subitems concerning affective disturbances

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Improved by 34%; SCAG total score improved by 30%.

CBF studies showed a trend toward a reduction in the CBF interhemi-

Spheric asymmetries in mtd patients treated with nic, while no significant

Results were obtained in AD patients. No changes were recorded in both

MID and AD patients after PI treatment.

Neurocognitive potentials and clinical status in

Primary presenile dementia. Eight-year follow up

Of chrontc treatment with nicergoline

R. Zappoli 1, G. Arnetoli 1, M. Paganini 1. D. Poggiolinil, A, battaglia 2,

K annoni 2, F, pamparana 2 1 department ofneuro-psych/atric sc/ences,

2nd neurological chnic, universw of florence, italy, 2 medical

Department, pharmacia, milan,/ta/y

The ma~n components of the CNV complex and reaction time (RT) to imper-

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Ative signals are sensitive to the changes in behaviour, alertness, concen-

Tration, memory and motivation.

Clinical neurephysiologists proved that CNV/RT and P300 are useful tools

For the diagnosis and the evaluation of dementia and mental impairment

Related to aging in particular CNV/RT complex can constitute a valuable

Clue to find out and characterize the early stages of pressnile mental dete-


The aim of the study was to verify the effects of long-term nicergo-

Hne treatment (eight years) on CNV/RT activity and mental impairment of

Pattents with presenile idiopathic cognitive decline (PICD) or with early

Symptoms of presenile alzheimer-type dementia (PAD).

So far the CNV/RT activity was recorded and analyzed with topographic

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Bit-mapping method in 11 patients with initial PICD, 6 with early symptoms

And signs of probable PAD and 10 healthy age*matched controls. All patients

Underwent through medical and laboratory assessments, including CT-scan

Or MRI examinations, EEG spectral analysis and a battery of psychometric

Tests A simple CNV paradigm ($1 clicks-2 sec ISI-S2 visual signals motor

Response with RT to S2) was used and each artifact-free response with 7

Leads and linked mastoid reference was analyzed with a method of spario-

Temporal topographic CNV complex, mapping separately at 4 indipendent

Temporal window-areas (WA} of 200 ms duration (/zvs} corresponding to

The most ~mportant and known CNV comoonents. EQG, RT and $1.What is anoxic encephalopathy S2

S gnals were also recorded.

Positive effects on CNV/RT activity and on clinical status were observed

For a long time in PICD patients and are still present in 5 out of 11 cases

Afte 8-year n~cergoline treatment. A transitory electro-clinical improvement

Was m~t~ally found also in 2 PAD patients, but after one-year treatment all

PAD pattents progressively worsened. No important drug-related adverse

Reactions were recorded.