A randomized study of H3 antagonist ABT-288 in mild-to-moderate Alzheimer's dementia.
J Alzheimers Dis
; 42(3): 959-71, 2014.
Article
en En
| MEDLINE
| ID: mdl-25024314
ABSTRACT
BACKGROUND:
ABT-288, a highly selective histamine-3 receptor antagonist, demonstrated efficacy across several preclinical cognitive domains, and safety in healthy subjects and elderly volunteers.OBJECTIVE:
Evaluate the efficacy and safety of ABT-288 in subjects with mild-to-moderate Alzheimer's dementia.METHODS:
The study used a randomized, double-blind, placebo- and active-controlled, parallel group design with pre-defined futility criteria to permit early study termination. A total of 242 subjects were randomized in an equal ratio to ABT-288 1 mg or 3 mg, donepezil 10 mg, or placebo once daily for 12 weeks. The primary efficacy endpoint was the change from baseline to final evaluation on the 13-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score.RESULTS:
The study was prematurely terminated because futility criteria were met. Point estimates on the ADAS-Cog scores for both ABT-288 dose groups were numerically inferior to placebo but no statistical differences were detected. Donepezil demonstrated statistically significant improvement. Adverse events were generally mild and self-limiting.CONCLUSION:
ABT-288 did not demonstrate efficacy in the symptomatic treatment of Alzheimer's dementia.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Piridazinas
/
Pirroles
/
Antagonistas de los Receptores Histamínicos H3
/
Enfermedad de Alzheimer
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Límite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
J Alzheimers Dis
Asunto de la revista:
GERIATRIA
/
NEUROLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos