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Galantamine (ReminylTM) (Hoechst Marion Roussel, Inc., Shire Pharmaceuticals Group and Janssen Pharmaceutica. Approved by FDA)

Primary medical role: Treatment for Alzheimer's disease.

Role in Alzheimer's disease: Improve cognitive function in mild/moderate AD.

Approved by FDA for Alzheimer's use?: Yes, in February, 2001.

Pharmacological role: Reversible cholinesterase inhibitor.

Contraindications: n/a

Side effects: Nausea, vomiting, other cholinergic effects (~10% vs. 5% controls), particularly in early weeks of ingestion.

Evidence pro its efficacy: In half of patients with mild to moderate forms of this disease, who usually worsen over time, cognitive scores and daily functions were maintained at or above baseline throughout one year of treatment. In trials of 3 to 6 months' duration, recipients of galantamine 16 or 24 mg/day achieved significant improvements in cognitive and global symptoms relative to placebo recipients. Galantamine also improved activities of daily living in these patients and significantly reduced the requirement for caregiver assistance with activities of daily living

Evidence con its efficacy: It is difficult to say that this medication offers advantages in efficacy over existing anticholinergics.

Dosage: Starting dosage at 8 mg/day, increase to 16mg/day after at least four weeks. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks.

Cost: N/A

References:

Davidsson P, Blennow K, Andreasen N, Eriksson B, Minthon L, Hesse C. Differential increase in cerebrospinal fluid-acetylcholinesterase after treatment with acetylcholinesterase inhibitors in patients with Alzheimer's disease. Neurosci Lett. 2001 Mar 16;300(3):157-160. Abstract.

Aerssens J, Raeymaekers P, Lilienfeld S, Geerts H, Konings F, Parys W. APOE Genotype: No Influence on Galantamine Treatment Efficacy Nor on Rate of Decline in Alzheimer's Disease. Dement Geriatr Cogn Disord. 2001 Mar;12(2):69-77. Abstract.

Woodruff-Pak DS, Vogel RW, Wenk GL. Galantamine: Effect on nicotinic receptor binding, acetylcholinesterase inhibition, and learning. Proc Natl Acad Sci U S A. 2001 Feb 13;98(4):2089-2094. Abstract.

Scott LJ, Goa KL. Galantamine: a review of its use in Alzheimer's disease. Drugs. 2000 Nov;60(5):1095-122. Abstract.

Sramek JJ, Frackiewicz EJ, Cutler NR. Review of the acetylcholinesterase inhibitor galanthamine. Expert Opin Investig Drugs. 2000 Oct;9(10):2393-402. Abstract.

Blesa R. Galantamine: therapeutic effects beyond cognition. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:28-34. Abstract.

Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. Abstract.

Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology. 2000 Jun 27;54(12):2269-76. Abstract.

Raskind MA, Peskind ER, Wessel T, Yuan W. Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology. 2000 Jun 27;54(12):2261-8. Abstract.

Bachus R, Bickel U, Thomsen T, Roots I, Kewitz H. The O-demethylation of the antidementia drug galanthamine is catalysed by cytochrome P450 2D6. Pharmacogenetics. 1999 Dec;9(6):661-8. Abstract.

Greenblatt HM, Kryger G, Lewis T, Silman I, Sussman JL. Structure of acetylcholinesterase complexed with (-)-galanthamine at 2.3 A resolution. FEBS Lett. 1999 Dec 17;463(3):321-6. Abstract.

Moraes-Cerdeira RM, Burandt CL Jr, Bastos JK, Nanayakkara D, Mikell J, Thurn J, McChesney JD. Evaluation of four Narcissus cultivars as potential sources for galanthamine
production. Planta Med 63(5):472-474 (Oct. 1997) Abstract.

Fulton B, Benfield P. Galanthamine. Drugs Aging 9(1):60-65 (Jul 1996) Abstract.

Bores GM, Huger FP, Petko W, Mutlib AE, Camacho F, Rush DK, Selk DE, Wolf V, Kosley RW Jr, Davis L, Vargas HM. Pharmacological evaluation of novel Alzheimer's disease therapeutics:acetylcholinesterase inhibitors related to galanthamine. J Pharmacol Exp Ther 277(2):728-738 (May 1996) Abstract.