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Galantamine Confers Benefits in Patients With Pure Vascular Dementia: Presented at AAN

By Jill Stein

SAN FRANCISCO, CA -- April 29, 2004 -- Galantamine significantly improves cognition in patients with pure vascular dementia, researchers reported here on April 27^th at the American Academy of Neurology 56^th Annual Meeting.

Alexander Auchus, MD, Clinical Director, University Memory and Aging Center, Case Western Reserve University, Cleveland, Ohio, presented results in 788 patients randomised to 26 weeks' treatment with placebo or to 8 or 12 mg BID of galantamine, an acetylcholinesterase inhibitor and allosteric modulator of nicotinic receptors.

All subjects had a diagnosis of vascular dementia according to criteria from the National Institute of Neurological Disorders and Stroke - Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN).

A central reader reviewed the magnetic resonance imaging scans obtained for all patients to confirm that NINDS-AIREN radiological criteria were met. Patients had a Mini-Mental State Exam score of 10 to 26 and the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog11) score 12 or greater.

In all cases, disease onset was between the ages of 40 and 90 years. Demographics, baseline characteristics, vascular dementia history, and risk factors were similar between the galantamine and control groups.

The researchers found that patients treated with galantamine 8 or 12 mg BID had a statistically significant improvement in cognitive function compared to placebo.

Results of the analysis of the change from baseline in the ASAS-cog/11 score at week 26 revealed a significant difference between the treatment groups in cognitive function favouring the active drug (P <.001).

Mean decrease from baseline to week 26 (last observation carried forward) in ADAS-cog 11 was 1.8 for galantamine and 0.3 for placebo. Decreases from baseline indicate improvement.

The Alzheimer's Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL), Clinician's Interview-Based Impression of Change CIBIC, and the 25-item Executive Interview (EXIT-25) scores improved in both groups.

The change from baseline to 26 weeks demonstrated no significant difference between the two groups for ADCS-ADL (P = -0.783). CIBIC analysis showed a statistically significant improvement favoring galantamine in EXIT-25 (P =.041), although this measure was only administered at sites in English-speaking countries.

Except for a higher incidence of insomnia and cholinergic-associated gastrointestinal adverse events, galantamine was similar to placebo in safety and tolerability.

Patients with vascular dementia have a high risk of morbidity and mortality. At present, there is no approved treatment available.

The study was sponsored by Johnson and Johnson Pharmaceutical Research and Development in Titusville, New Jersey.


[Presentation title: "Results of a trial of galantamine in subjects with vascular dementia confirmed by central MRI reading." Abstract #LBS 1]

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