title: Sustained effects of once-daily memantine treatment on cognition and functional communication skills in patients with moderate to severe Alzheimer's disease: results of a 16-week open-label trial.
abstract: The present study evaluated the effects of once-daily memantine (20 mg) treatment on cognition and communication in patients with moderate to severe Alzheimer's disease (AD). In a multicenter, single-arm open-label study, outpatients diagnosed with AD (MMSE < 20; n = 97) were titrated from 5 mg to 20 mg once-daily memantine over 4 weeks. Once-daily memantine treatment (20 mg) was then continued for 8 weeks, followed by a 4-week wash-out period. The primary efficacy endpoint was the change from baseline in the Consortium to Establish a Registry for Alzheimer's Disease -Neuropsychological Battery (CERAD-NP) total score. Secondary efficacy endpoints included change from baseline in Functional Communication Language Inventory (FLCI) and ADCS-ADL19 total score, and the response from baseline in Clinical Global Impression of Change (CGI-C). The CERAD-NP total score improved significantly after 12 weeks of once-daily memantine treatment compared with baseline (5.9 ± 8.8; p < 0.0001). The FLCI total score improved significantly after 12 weeks compared with baseline (4.4 ± 6.8; p < 0.0001). These significant improvements were already observed after 4 and 8 weeks of once-daily memantine treatment and persisted after a 4-week wash-out period. ADCS-ADL19 total scores showed only slight increases from baseline, and CGI-C indicated that the majority of patients experienced an improvement or stabilization of the disease after 12 weeks. At least one Treatment-Emergent Adverse Event was reported by 38 (39.2%) patients. In patients with moderate to severe AD, once-daily memantine (20 mg) treatment significantly improved cognition and functional communication and was found to have a favorable safety and tolerability profile.
authors.affiliation: Department of Neurology, University Medical Center, RWTH Aachen, Aachen, Germany. jschulz@ukaachen.de
authors.forename: Jörg B
authors.initials: JB
authors.lastname: Schulz
authors.forename: Michael
authors.initials: M
authors.lastname: Rainer
authors.forename: Hans-Hermann
authors.initials: HH
authors.lastname: Klünemann
authors.forename: Alexander
authors.initials: A
authors.lastname: Kurz
authors.forename: Stefanie
authors.initials: S
authors.lastname: Wolf
authors.forename: Kati
authors.initials: K
authors.lastname: Sternberg
authors.forename: Frank
authors.initials: F
authors.lastname: Tennigkeit
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications / Q000188:drug therapy; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology; D003142:Communication; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D018691:Excitatory Amino Acid Antagonists / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008559:Memantine / Q000627:therapeutic use*; D008875:Middle Aged; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D015203:Reproducibility of Results; D013064:Speech Disorders / Q000188:drug therapy* / Q000209:etiology
chemical_list: D018691:Excitatory Amino Acid Antagonists; D008559:Memantine