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

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

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, randomized clinical trial, we studied the efficacy of long-term (1-year) oral treatment with acetyl-L-carnitine in 130 patients with a clinical diagnosis of Alzheimer's disease. We employed 14 outcome 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 deterioration in 13 of the 14 outcome measures, reaching statistical significance for the Blessed Dementia Scale, logical intelligence, ideomotor and buccofacial apraxia, and selective attention. Adjusting for initial scores with analysis of covariance, the treated group showed better scores on all outcome measures, reaching statistical significance for the Blessed Dementia Scale, logical intelligence, verbal critical abilities, long-term verbal memory, and selective attention. The analysis for patients with good treatment compliance showed a greater drug benefit than for the overall sample. Reported adverse events were relatively mild, 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. Frattura is a "Centro di Formazione e Studi per il Mezzogiorno - Formez" fellow.

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




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