Multiple metabolic pathways and renal excretion eliminate galantamine, so no single pathway appears dominant. The main enzymes involved in the metabolism of galantamine, according to in vitro studies, were CYP2D6 and CYP3A4. The formation of O-desmethyl-galantamine was mediated by CYP2D6, while CYP3A4 mediated galantamine-N-oxide. Galantamine hydrobromide powder is also glucuronidated and excreted in the urine unchanged. You can click for more information.
Clinical Trials
The results of five randomized, double-blind, placebo-controlled clinical trials in patients with probable Alzheimer’s disease, four with the immediate-release tablet and one with the extended-release capsule demonstrate the efficacy of galantamine as a treatment for Alzheimer’s disease. The tablet formulation was tested with doses ranging from 8 to 32 mg twice daily. Patients were started on a low dose of 8 mg in three of the four trials with the tablet, then titrated weekly by 8 mg/day to 24 or 32 mg as assigned.
Dose escalation of 8 mg/day occurred over 4-week intervals in the fourth study (USA 4-week Dose Escalation Fixed-Dose Study). Patients in these four galantamine trials ranged in age from 41 to 100 years old on average. Women made up 62 percent of the patients, while men made up 38 percent. Whites made up 94% of the population, Blacks 3%, and people of other races 3%. Two other research looked at a three-times-daily dosing regimen; both found or indicated benefit but no advantage over twice-daily dosing.
Measures of the Study’s Outcomes
The primary efficacy of galantamine was assessed in each study using a dual outcome evaluation strategy involving the Alzheimer’s Disease Assessment Scale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change use of caregiver data (CIBIC-plus).
The cognitive subscale of the Alzheimer’s disease Assessment Scale (ADAS-cog), a multi-item instrument that has been widely validated in longitudinal cohorts of Alzheimer’s disease patients, was used to evaluate galantamine’s ability to increase cognitive efficiency. The ADAS-cog looks at memory, orientation, attention, thought, vocabulary, praxis, and other aspects of cognitive ability. The ADAS-cog scale runs from 0 to 70, with higher scores suggesting more severe cognitive impairment. Standard elderly adults may receive a score of 0 or 1, although it is not uncommon for non-demented adults to receive a slightly higher score.
The patients who took part in each study using the tablet formulation had an average ADAS-cog score of about 27 units, ranging from 5 to 69. Longitudinal studies of ambulatory patients with mild to moderate Alzheimer’s disease have shown that they gain 6 to 12 ADAS-cog units per year. Patients with very moderate or very advanced disease, on the other hand, see less improvement because the ADAS-cog is not universally susceptible to change throughout the disease. In galantamine trials, the annualized rate of decline in placebo patients was approximately 4.5 units per year. You can get more information from https://www.wisepowder.com/product-details/272786-64-8/.
