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Titolo:
A 30-WEEK RANDOMIZED CONTROLLED TRIAL OF HIGH-DOSE TACRINE IN PATIENTS WITH ALZHEIMERS-DISEASE
Autore:
KNAPP MJ; KNOPMAN DS; SOLOMON PR; PENDLEBURY WW; DAVIS CS; GRACON SI; APTER JT; LAZARUS CN; BAKER KE; BARNETT M; BAUMEL B; EISNER LS; CASTELLS B; BOLOURI R; BENNETT D; FORCHETTI C; LEVIN A; BLASS JP; NOLAN KA; GAINES ER; RELKIN N; BORISON RL; DIAMOND B; CELESIA GG; ROSS AP; DEXTER J; DOODY R; LIPSCOMB L; KREITER K; DUBOFF EA; BLOCK P; MARSHALL D; WESTERGAARD N; EARL NL; WYNE SV; HINMANSMITH E; FARLOW M; HENDRIE HC; CARESS JA; FARMER M; HARPER JE; FERGUSON J; FOSTER NL; BARBAS NR; BLUEMLEIN LA; GELB DJ; BERENT S; GIORDANI B; GREENWALD M; BERGMAN S; ROGER LF; GROENENDYK A; WOOD M; JURKOWSKI C; KATZ I; DOYLE S; SMITH BD; KELLNER C; BERNSTEIN HJ; BACHMAN DL; KNOPMAN DS; DEINARD S; LANGLEY L; BRIDGES S; MARGOLIN RA; BURGER MC; WISER SL; CRENSHAW C; MORRIS JC; RUBIN EH; COATS MA; REYES PF; BENTZ C; DOYLE LL; RYMER MM; BETTINGER IE; LAUBINGER MP; SADOWSKY CH; MARTINEZ W; ZUNIGA J; STONE R; WINNER P; MATE L; LESSARD C; SCHNEIDER L; PAWLUCZYK S; SMITH WT; LOSK SN; MARAMBE L; SOLOMON PR; PENDLEBURY WW; GROCCIAELLISON ME; EDWARDS KR; TAYLOR J; CALABRESE VP; HARKINS SW; THEIN SG; DEWAR JA; WILLIAMS G; DRENNAN C; TUTTLE P; PRINCIPI N; FORD EM; TYNDALL RJ; KELLEY CK;
Indirizzi:
PARKE DAVIS & CO,PHARMACEUT RES,CLIN RES DEPT,2800 PLYMOUTH RD ANN ARBOR MI 48106 UNIV MINNESOTA,DEPT NEUROL MINNEAPOLIS MN 55455 WILLIAMS COLL,DEPT PSYCHOL WILLIAMSTOWN MA 01267 UNIV VERMONT,DEPT PATHOL BURLINGTON VT 05405 UNIV IOWA,COLL MED,DIV BIOSTAT IOWA CITY IA 52242 PRINCETON BIOMED RES PRINCETON NJ 00000 NEURO MED RES ASSOCIATES MIAMI BEACH FL 00000 RUSH ALZHEIMERS DIS CTR CHICAGO IL 00000 CORNELL UNIV,COLL MED WHITE PLAINS NY 10605 DOWNTOWN VET AFFAIRS MED CTR AUGUSTA GA 00000 LOYOLA UNIV,MED CTR MAYWOOD IL 60153 UNIV MISSOURI,HLTH SCI CTR COLUMBIA MO 65201 BAYLOR COLL MED HOUSTON TX 77030 CTR BEHAV MED WHEAT RIDGE CO 00000 MEMORY DISORDERS CLIN DURHAM NC 00000 INDIANA UNIV,CTR ALZHEIMERS DIS & RELATED DISORDERS INDIANAPOLIS IN 46204 CLIN STUDIES FLORIDA ST PETERSBURG FL 00000 PHARMACOL RES CORP SALT LAKE CITY UT 00000 UNIV MICHIGAN,MED CTR ANN ARBOR MI 48109 SW INST CLIN RES RANCHO MIRAGE CA 00000 MEM HOSP BURLINGTON CTY MT HOLLY NJ 00000 MED COLL PENN PHILADELPHIA PA 19129 MED UNIV S CAROLINA CHARLESTON SC 29425 UNIV MINNESOTA,SCH MED MINNEAPOLIS MN 55455 VANDERBILT UNIV,MED CTR,SCH MED NASHVILLE TN 37232 WASHINGTON UNIV,SCH MED ST LOUIS MO 63110 THOMAS JEFFERSON UNIV,JEFFERSON MED COLL PHILADELPHIA PA 19107 VIRGINIA COMMONWEALTH UNIV,MED COLL VIRGINIA RICHMOND VA 23298 PACIFIC RES NETWORK SAN DIEGO CA 00000 CAROLINA NEUROL CLIN CHARLOTTE NC 00000 CLIN TRIALS CTR SPRINGFIELD MO 00000 CTR CLIN NEUROL STUDIES KANSAS CITY MO 00000 W PALM BEACH NEUROL GRP W PALM BEACH FL 00000 UNIV SO CALIF LOS ANGELES CA 90089 PACIFIC NW RES CTR PORTLAND OR 00000 SW VERMONT MED CTR BENNINGTON VT 00000
Titolo Testata:
JAMA, the journal of the American Medical Association
fascicolo: 13, volume: 271, anno: 1994,
pagine: 985 - 991
SICI:
0098-7484(1994)271:13<985:A3RCTO>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
SENILE DEMENTIA; CHOLINERGIC NEURONS; SELECTIVE LOSS; DOUBLE-BLIND; PROGRESSION; IMPAIRMENT; TETRAHYDROAMINOACRIDINE; MULTICENTER; SCALE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
28
Recensione:
Indirizzi per estratti:
Citazione:
M.J. Knapp et al., "A 30-WEEK RANDOMIZED CONTROLLED TRIAL OF HIGH-DOSE TACRINE IN PATIENTS WITH ALZHEIMERS-DISEASE", JAMA, the journal of the American Medical Association, 271(13), 1994, pp. 985-991

Abstract

Objective.-To evaluate the efficacy and safety of high-dose tacrine hydrochloride over 30 weeks in patients with probable Alzheimer's disease. Design.-A 30-week randomized, double-blind, placebo-controlled, parallel-group trial. Setting.-Outpatients at 33 US centers. Patients.-Men and women at least 50 years of age with mild to moderate Alzheimer's disease and otherwise in good health. Interventions.-Group 1 received placebo; group 2 received 40 mg/d of tacrine for 6 weeks, then 80 mg/d for 24 weeks; groups 3 and 4 received 40 mg/d of tacrine for 6 weeks, 80 mg/d for 6 weeks, and 120 mg/d for 6 weeks. Group 3 remained on a dosage of 120 mg/d for a total of 18 weeks; after 6 weeks at 120 mg/d, group 4 titrated to 160 mg/d for the last 12 weeks. Primary OutcomeMeasures.-Clinician Interview-Based Impression (CIBI), Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), and Final Comprehensive Consensus Assessment (FCCA). Results.-A total of 663 patients entered the study; 653 patients were included in an intent-to-treat (ITT) analysis; 263 had evaluable data at 30 weeks. The results of the ITT analysis revealed significant (P less-than-or-equal-to .05) dose-response trends and between-group comparisons on CIBI and ADAS-Cog. In evaluable patients, significant dose-response trends were observed for all three primary measures (P less-than-or-equal-to .001). Significantdifferences in favor of 160 mg/d of tacrine vs placebo were observed on the CIBI (P less-than-or-equal-to .002) and ADAS-Cog and FCCA (P less-than-or-equal-to .001), as well as caregiver-global and quality-of-life assessments (P less-than-or-equal-to .05). On the CIBI, 23% and 42% of tacrine-treated patients in the ITT and evaluable-patient populations, respectively, were rated improved compared with 17% and 18% of placebo patients, respectively. The primary reasons for withdrawal of tacrine-treated patients were asymptomatic liver transaminase elevations (28%) and gastrointestinal complaints (1 6%). These adverse events were reversible on discontinuation of treatment, and many patients were able to restart tacrine. Conclusions.-Tacrine produced statisticallysignificant, dose-related improvements on objective performance-basedtests, clinician- and caregiver-rated global evaluations, and measures of quality of life. There was no evidence that the large number of patient withdrawals biased the overall conclusions of the study.

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Documento generato il 04/07/20 alle ore 20:17:48