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P1‐272: Opposite effects of cerebrolysin on serum TNF‐alpha and IGF‐I levels in Alzheimer's disease
Author(s) -
Alvarez Anton,
Sampedro Carolina,
Cacabelos Ramon,
Novak Philip,
Moessler Herbert
Publication year - 2009
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2009.04.280
Subject(s) - cerebrolysin , placebo , medicine , saline , tumor necrosis factor alpha , alpha (finance) , neuroinflammation , endocrinology , gastroenterology , disease , surgery , pathology , construct validity , alternative medicine , patient satisfaction
Background: Post hoc analyses of placebo-controlled studies suggest that memantine treatment may benefit language and conversation abilities of patients’ with Alzheimer’s disease (AD). This study prospectively evaluated the effects of memantine on functional communication in patients with moderate AD. Methods: Native English-speaking outpatients (N1⁄4265) with AD (MMSE range: 10-19) participated in a 12-week, international, double-blind, randomized, placebo-controlled study of memantine (20 mg/day) versus placebo. Concurrent cholinesterase inhibitor treatment, stable throughout the study, was permitted but not required. The primary outcome was the baseline-to-endpoint score change on the Functional Linguistic Communication Inventory (FLCI), a patient performance measure; secondary outcome was the baseline-to-endpoint score change on the combined Social Communication and Communication of Basic Needs subscales of the American SpeechLanguage-Hearing Association Functional Assessment Communication Skills for Adults (ASHA FACS), a caregiver assessment. Primary analysis was based on the intent-to-treat population and the last observation carried forward (LOCF) approach, performed using a two-way ANCOVA model with treatment group and study center as factors, and baseline score as covariate. Further analyses were based on the observed cases (OC) and the mixed-effects model with repeated measures (MMRM; FLCI only). Safety and tolerability were assessed by recording treatment-emergent adverse events (TEAEs). Results: Patients treated with memantine (n1⁄4133) demonstrated a statistically significant (LOCF) improvement on the FLCI at Weeks 4 and 8, and trend at Week 12 (placebo: -0.6; memantine: 0.7; P1⁄40.070) when compared with patients treated with placebo (n1⁄4124); improvement on the ASHA FACS was significant at Weeks 8 and 12 (placebo: -5.3; memantine: 0.5; P1⁄40.022). Analyses based on OC (FLCI; ASHA FACS) and MMRM (FLCI) yielded similar results. Memantine was well tolerated; only dizziness and restlessness were reported by 2% of memantine patients and at an incidence twice that observed in the placebo group. Conclusions: Treatment of patients with moderate AD with memantine improves functional communication skills which can be recognized by caregivers.