Long-term acetyl-L-carnitine treatment in Alzheimer's disease.

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Long-term acetyl-L-carnitine treatment in Alzheimer's disease

NEUROLOGY 1991;41:1726
© 1991 American Academy of Neurology

A. Spagnoli, MD, U. Lucca, PhD, G. Menasce, MD, L. Bandera, MD, G. Cizza, MD, G. Forloni, PhD, M. Tettamanti, PhD, L. Frattura, MD, P. Tiraboschi, MD, M. Comelli, PhD, U. Senin, MD, A. Longo, MD, A. Petrini, MD, G. Brambilla, MD, A. Belloni, PhD, C. Negri, MD, F. Cavazzuti, MD, A. Salsi, MD, P. Calogero, MD, E. Parma, MD, M. Stramba-Badiale, MD, S. Vitali, MD, G. Andreoni, MD, M. R. Inzoli, MD, G. Santus, MD, R. Caregnato, MD, M. Peruzza, MD, M. Favaretto, MD, C. Bozeglav, PhD, M. Alberoni, MD, D. De Leo, MD, L. Serraiotto, MD, A. Baiocchi, MD, S. Scoccia, MD, P. Culotta, MD and D. Ieracitano, MD

Mario Negri Institute for Pharmacological Research (Drs. Spagnoli, Lucca, Menasce, Bandera, Cizza, Forloni, Tettamanti, Frattura, and Tiraboschi), Milan; Department of Medical Statistics (Dr. Comelli), Istituto di Scienze Sanitarie Applicate, University of Pavia; Dipartimento di Geriatria e Gerontologia (Prof. Senin and Drs. Longo and Petrini), University of Perugia; Pio Albergo Trivulzio (Drs. Brambilla, Belloni, and Negri), Milan; Ospedale Malpighi (Prof. Cavazzuti and Drs. Salsi and Calogero), Bologna; Clinica Zucchi (Dr. Parma), Monza; Istituto Golgi (Drs. Stramba-Badiale, Vitali, and Andreoni), Abbiategrasso; Ospedale S. Orsola (Drs. Inzoli, Santus, and Caregnato), Brescia; Ospedale Giustinian (Prof. Peruzza and Drs. Favaretto and Bozeglav), Venice; Gruppo di Neuropsicologia, Clinica Neurologica I (Dr. Alberoni), University of Milan; Servizio di Psicogeriatria (Prof. De Leo and Drs. Serraiotto and Baiocchi), University of Padua; and Istituto Don Orione (Prof. Scoccia and Drs. Culotta and and Ieracitano), Milan, Italy.

In a double-blind, placebo-controlled, parallel-group, randomizedclinical trial, we studied the efficacy of long-term (1-year)oral treatment with acetyl-L-carnitine in 130 patients witha clinical diagnosis of Alzheimer's disease. We employed 14outcome measures to assess functional and cognitive impairment.After 1 year, both the treated and placebo groups worsened,but the treated group showed a slower rate of deteriorationin 13 of the 14 outcome measures, reaching statistical significancefor the Blessed Dementia Scale, logical intelligence, ideomotorand buccofacial apraxia, and selective attention. Adjusting for initial scores with analysis of covariance, the treatedgroup showed better scores on all outcome measures, reachingstatistical significance for the Blessed Dementia Scale, logicalintelligence, verbal critical abilities, long-term verbal memory,and selective attention. The analysis for patients with goodtreatment compliance showed a greater drug benefit than forthe overall sample. Reported adverse events were relativelymild, and there was no significant difference between the treated and placebo groups either in incidence or severity.

Address correspondence and reprint requests to Dr. A. Spagnoli, Istituto Mario Negri, Via Eritrea 62, 20157 Milan, Italy.

Supported in part by Sigma-Tau, Pomezia, Rome. Dr. Fratturais a "Centro di Formazione e Studi per il Mezzogiorno - Formez"fellow.

Received August 14, 1990. Accepted for publication in finalform April 16, 1991.

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