title: Effects of galantamine in Alzheimer's disease: double-blind withdrawal studies evaluating sustained versus interrupted treatment.
abstract: To evaluate the effects of galantamine withdrawal, and compare this with uninterrupted therapy, two 6-week double-blind withdrawal studies (Studies 1 and 2) were performed. These enrolled individuals who had completed one of two 3- or 5-month randomized clinical trials (parent trials) involving patients with mild to moderate Alzheimer's disease (AD). In Study 1 (GAL-USA-11; n'723), patients continuously treated with galantamine 16 mg/day exhibited a mean (± standard error [SE]) improvement in 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale score of 1.8 (± 0.46) points at Week 6 compared with the parent trial baseline, (p < 0.001 vs placebo; observed cases analysis). Over the same period, patients switched from galantamine to placebo and those who had received continuous placebo, exhibited mean (± SE) deteriorations of 0.7 (± 0.49) and 1.2 (± 0.49) points, respectively. Similar trends were apparent in Study 2 (GAL-USA-5; n=118). In Study 1, subgroup analyses demonstrated cognitive benefits with continuing galantamine treatment and deterioration associated with galantamine withdrawal in patients with advanced moderate AD (baseline Mini-Mental State Examination score ≤14) and in individuals deemed non-responsive in terms of Clinician's Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus) evaluation at the end of the parent trial (CIBIC-plus score > 4). No safety issues were identified. In patients with mild to moderate AD who have exhibited cognitive benefits from up to 5 months' galantamine treatment, continuing therapy reinforces previously achieved benefit, whereas in patients in whom galantamine is discontinued, although no safety concerns arise, the natural progression of AD is apparent.
authors.affiliation: Janssen-Cilag GmbH, Neuss, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Gaudig
authors.forename: U
authors.initials: U
authors.lastname: Richarz
authors.forename: J
authors.initials: J
authors.lastname: Han
authors.forename: B
authors.initials: B
authors.lastname: Van Baelen
authors.forename: B
authors.initials: B
authors.lastname: Schäuble
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage*; D005260:Female; D005702:Galantamine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D005702:Galantamine