Effects of intravenous high dose co-dergocrine mesylate ('Hydergine') in elderly patients with severe multi-infarct dementia: a double-blind, placebo-controlled trial.
A double-blind, placebo-controlled trial was carried out in 40 patients affected by multi-infarct dementia to see if a daily intravenous infusion of 3 mg co-dergocrine mesylate ('Hydergine') over 14 days would improve severely deteriorated elderly patients and shorten the latent period (3 months) which is observed when the drug is given orally. All the patients had severe mental impairment, psychological deficit or altered consciousness. A Hachinski score of 7 or more, and a cumulative score of at least 12 points on SCAG scale Items 1, 2 and 4 (anxiety/depression) and/or Items 5, 6 and 8 (alertness/confusion) were required for admission. After 1 week of intravenous infusion of placebo, patients were randomly allocated to treatment with co-dergocrine mesylate or placebo, from Day 1 to Day 14. The solutions were infused over a period of 2 hours. During the follow-up period from Day 15 to Day 21, the patients did not receive any treatment. Thirty-six patients (17 on co-dergocrine mesylate, 19 on placebo) completed the study. The results, as rated on the SCAG scale, indicated significant improvements, in favour of co-dergocrine mesylate, in cognitive dysfunction, mood depression, withdrawal and overall impression. Furthermore, the factor fatigue on the Nowlis scale and clinical global assessments by physicians also showed significant advantages of the co-dergocrine mesylate group over placebo. Nine out of 17 co-dergocrine mesylate patients complained of side-effects, usually experienced during infusion; they consisted mainly of nausea (6 patients), gastric discomfort (2 patients), and tremor, nasal congestion, flushing, hypotension and hypertension (1 patient each). Despite the appearance of side-effects, general tolerability was rated as 'good' by both physicians and patients. It is concluded, therefore, that intravenous high dose co-dergocrine mesylate treatment has a fast and clinically relevant effect on the key clinical symptoms of multi-infarct dementia.
Arrigo
A
A
Università degli Studi, Centro di Neurologia Clinica, Pavia, Italy.
Casale
R
R
Giorgi
I
I
Guarnaschelli
C
C
Zelaschi
F
F
D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D015161:Dementia, Multi-Infarct / Q000188:drug therapy*; D004088:Dihydroergotoxine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010919:Placebos
D010919:Placebos; D004088:Dihydroergotoxine