Alzheimer Research Forum Overview of Razadyne (galantamine)

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Name: Galantamine

Other Names: Reminyl™, Razadyne™

Mechanisms: cholinesterase inhibitor

Development Status: approved in U.S.

FDA Phase: FDA approved

Primary Medical Role: Treatment for Alzheimer's disease.

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

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.

Notes: See ARF news story published on 26 Jan 2005 and statement on Johnson & Johnson web site regarding review of safety data.

See Medline Plus Drug Information: Galantamine [MedMaster] and Galantamine (Systemic) [USP DI] .

References

Cummings JL, Schneider L, Tariot PN, Kershaw PR, Yuan W. Reduction of behavioral disturbances and caregiver distress by galantamine in patients with Alzheimer's disease. Am J Psychiatry. 2004 Mar ;161(3):532-8. Abstract

Raskind MA. Update on Alzheimer drugs (galantamine). Neurolog. 2003 Sep; 9(5):235-40. Abstract

Mintzer JE, Kershaw P. The efficacy of galantamine in the treatment of Alzheimer's disease: comparison of patients previously treated with acetylcholinesterase inhibitors to patients with no prior exposure. Int J Geriatr Psychiatry. 2003 Apr;18(4):292-7. Abstract

Cummings JL. Use of cholinesterase inhibitors in clinical practice: evidence-based recommendations. Am J Geriatr Psychiatry. 2003 Mar-Apr ;11(2):131-45. Abstract

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-Apr ;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):2089-94. 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

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
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