ergoline and Dementia

Topics: Amantadine; Antiparkinson Agents; Atrophy; Brain; Bromocriptine; Cognition; Dementia; Dreams; Drug Interactions; Ergolines; Humans; Levodopa; Libido; Memory; Parasympatholytics; Parkinson Disease; Receptors, Dopamine; Sexual Behavior; Substance-Related Disorders; Visual Perception

In view of some controversies still existing about the real efficacy of ergot derivatives in the management of dementia, a double-blind, randomized, parallel group trial extending up to 6 months was carried out to compare the effects of nicergoline, 60 mg daily, and placebo in 315 patients suffering from mild to moderate dementia. Clinical evaluation was performed by the SCAG scale. The trial, which included a 1-month placebo run-in period, showed that both placebo and nicergoline were associated with some degree of improvement. The effect of nicergoline, however, was significantly greater and more sustained, steadily increasing with time. In particular, the difference between nicergoline and placebo in mean total SCAG score was 5.5 at 3 months (95% confidence interval: 3.6-7.4) and increased to 9.8 at 6 months (95% confidence interval: 7.8-11.8). A comparison of nicergoline versus placebo in the frequencies of changes in each item of the SCAG showed also a significant difference at 6 months, the percent of patients displaying an improvement by at least 2 points ranging from 13.5 (bothersome) to 30.2 (disorientation) in nicergoline group, against 4.1 (self-care) to 14.3 (fatigue) in placebo group. The safety of nicergoline, as judged by hemodynamic changes and drug-related adverse reactions, was quite satisfactory.

Topics: Aged; Aged, 80 and over; Clinical Trials as Topic; Dementia; Double-Blind Method; Ergolines; Female; Hemodynamics; Humans; Male; Middle Aged; Multicenter Studies as Topic; Nicergoline; Random Allocation

In a double-blind study, clinical, psychometric and neurophysiological changes were investigated in patients with MID treated by two different drug administration schedules of nicergoline (20 mg evenings versus 10 mg b.i.d.). 24 hospitalized patients (4 males, 20 females) with a mean age of 78 years were included according to the criteria of DSM-III, an Ischemic-Score of at least 7 points and a specific computed tomogram (CT). After a placebo-period of 2 weeks all patients were randomly assigned to an 8-weeks-treatment with either 20 mg nicergoline h.s. or 2 x 10 mg b.i.d. The evaluation of the detailed psychopathology by means of SCAG, CGI, NOSIE, Hamilton-Depressions-Scale and Mini-Mental-Status, as well as psychometric investigations by means of the Nuremberg-Aging-Inventory (NAI), thymophysic and psychophysiological measurements showed a significant improvement in both groups as compared with pre-treatment. This improvement was observed slightly earlier in patients with 20 mg h.s. than in those on the b.i.d. schedule. However inter-group-differences reached the level of statistical significance in only 2 variables. Neurophysiological investigations by means of topographic brain-mapping showed interesting relations between functional EEG-images and morphological CT-images. Vigilance-improving patients showed a better therapeutic response than those who did not show neurophysiological changes indicative of improvement in vigilance. Our findings suggest, that a single dose once daily was at least equal to the b.i.d. administration as far as therapeutic efficacy was concerned, even more so in the light of an expected improvement of compliance.

Topics: Aged; Aged, 80 and over; Clinical Trials as Topic; Dementia; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Electroencephalography; Ergolines; Evoked Potentials; Female; Humans; Male; Middle Aged; Neuropsychological Tests; Nicergoline; Psychometrics

In 1,366 patients the effect of Nicergoline (Sermion) on symptoms was recorded for one year. Individual symptoms improved to varying degrees in the patients observed. Many influences were responsible for the recorded improvement in the condition of the patients. These included, apart from the selection, placebo effects, the effect of suggestion, increased personal attention due to the need for monitoring examinations, and the pharmacodynamic effects of the active substance. The fact that the improvement rate of several symptoms such as lack of concentration, impairment of memory, decrease in alertness, dizziness and noises in the ear was analogous to that found in placebo-controlled doubleblind studies of other workers permits the assumption, that not so much the effects of placebo and suggestion but above all the pharmacodynamics of the active substance was the important factor. Treatment, which lasted for a year resulted in an improvement in some symptoms even during the second half of the year but not in others. This provides information on the indication for long-term treatment. Analysis of the individual parameters throws light on the reliability of the information provided by the examining physician, the patient compliance and the psychological effects of the physician's activities. Parameterized values are sometimes recorded more reliably by interested auxiliary medical staff than by physicians who feel alienated from their proper duty by such technical tasks.

Topics: Aged; Attention; Blood Pressure; Clinical Trials as Topic; Dementia; Ergolines; Female; Humans; Male; Mental Recall; Middle Aged; Nicergoline; Psychomotor Performance

Topics: Aged; Clinical Trials as Topic; Dementia; Double-Blind Method; Ergolines; Female; Humans; Intelligence Tests; Male; Nicergoline; Placebos

Based on "quantitative pharmaco-EEG" using computer-analyzed EEG (CEEG) measurements, unknown CNS effects of lisuride hydrogen maleate (LHM) were established. CEEG profiles of LHM in low dosages (less than or equal to 10 mcg) are similar to CNS "inhibitory" compounds, while in higher dosages (25 mcg to 100 mcg) they resemble "psychostimulant" compounds. By measuring the brain function using computer period analysis of cerebral biopotentials, dose-efficacy relations were found (in the range of 25-75 mcg) which suggest the bioavailability of LHM at the CNS level. By comparing the CEEG profiles of LHM with the previously studied compounds, five different clinical uses of LHM were predicted. The pilot trials suggest that LHM may have therapeutic potentials in patients with "aging" and/or organic brain syndromes, and in children with behavioral disturbances.

Topics: Adolescent; Adult; Aged; Biological Availability; Child; Child, Preschool; Clinical Trials as Topic; Computers; Dementia; Dextroamphetamine; Diazepam; Drug Evaluation; Electroencephalography; Ergolines; Humans; Hyperkinesis; Isocarboxazid; Methylphenidate; Middle Aged; Migraine Disorders; Obesity; Pilot Projects; Psychophysiologic Disorders; Psychotropic Drugs; Schizophrenia; Urea

Topics: Age Factors; Aged; Cerebrovascular Circulation; Cerebrovascular Disorders; Clinical Trials as Topic; Dementia; Ergolines; Female; Humans; Male; Neurologic Examination; Projective Techniques; Psychological Tests; Vasodilator Agents