Experiment 67104
Worktypes
Compounds isolated
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Empty organism |
| Citation | RASKIND,MA: PESKIND,ER: WESSEL,T: YUAN,W:. (2000). GALANTAMINE IN AD, A 6-MONTH RANDOMIZED, PLACEBO-CONTROLLED TRIAL WITH 6-MONTH EXTENSION.. 54(12) |
| Amount utilized | |
| Compound isolated | |
| Disease | GALANTAMINE IS A REVERSIBLE, COMPETITIVE CHOLINESTERASE INHIBITOR THAT ALSO ALLOSTERICALLY MODULATES NICOTINE ACETYLCHOLINE RECEPTORS. THESE MECHANISMS OF ACTION PROVIDED THE RATIONALE FOR A THERAPEUTIC TRIAL OF GALANTAMINE IN AD. A 6-MONTH, MULTICENTER, DOUBLE-BLIND TRIAL WAS UNDERTAKEN IN 636 PATIENTS WITH MILD TO MODERATE AD. PATIENTS WERE RANDOMLY ASSIGNED TO PLACEBO OR GALANTAMINE AND ESCALATED TO MAINTENANCE DOSES OF 24 OR 32 MG/D. ELIGIBLE PATIENTS THEN ENTERED A 6-MONTH, OPEN-LABEL STUDY OF THE 24 MG/D DOSE. PRIMARY EFFICACY MEASURES WERE THE 11 ITEM AD ASSESSMENT SCALE COGNITIVE SUBSCALE(ADAS-COG/11) AND THE CLINICIAN'S INTERVIEW-BASED IMPRESSION OF CHANGE PLUS CAREGIVER INPUT(CIBIC-PLUS). THE DISABILITY ASSESSMENT FOR DEMENTIA(DAD) SCALE WAS A SECONDARY EFFICACY VARIABLE. GALANTAMINE SIGNIFICANTLY IMPROVED COGNITIVE FUNCTION RELATIVE TO PLACEBO;THE TREATMENT EFFECTS WERE 3.9 POINTS(LOWER DOSE) AND 3.8 POINTS(HIGHER DOSE) ON THE ADAS-COG/11 SCALE AT MONTH 6(P<0.001 IN BOTH CASES). BOTH DOSES OF GALANTAMINE PRODUCED A BETTER OUTCOME ON CIBIC-PLUS THAN PLACEBO(P<0.05). THERAPEUTIC RESPONSE TO GALANTAMINE WAS NOT AFFECTED BY APOE GENOTYPE. AT 12 MONTHS, MEAN ADAS-COG/11 AND DAD SCORES HAD NOT SIGNIFICANTLY CHANGED FROM BASELINE FOR PATIENTS WHO RECEIVED GALANTAMINE 24MG/D THROUGHOUT THE 12 MONTHS. THE MOST COMMON ADVERSE EVENTS, WHICH WERE PREDOMINANTLY GASTOINTESTINAL, DECREASED IN FREQUENCY DURING LONG-TERM TREATMENT. THERE WAS NO EVIDENCE OF HEPATOTOXICITY. GALANTAMINE IS EFFECTIVE AND SAFE IN AD. AT 6 MONTHS, GALANTAMINE SIGNIFICANTLY IMPROVED COGNITION AND GLOBAL FUNCTION. MOREOVER, COGNITIVE AND DAILY FUNCTION WERE MAINTAINED FOR 12 MONTHS WITH THE 24MG/D DOSE. |
| Dose amount | 24.0 MG |
| Number | 1 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | DAY |
| Dose expression | DOSE |
| Gender | GIVEN TO BOTH SEXES |