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Retrospective cohort study of the efficacy of caprylic triglyceride in patients with mild-to-moderate alzheimer's disease.

ABSTRACT: BACKGROUND:The purpose of this study was to evaluate the effects of caprylic triglyceride (CT) in patients with mild-to-moderate Alzheimer's disease (AD) in routine clinical practice via review of medical records and caregiver questionnaires. METHODS:Participants were outpatients aged ?50 years with a diagnosis of probable mild-to-moderate AD who had received CT for ?6 months. The primary outcome was change from baseline in the patient's condition as rated by the treating physician using a physician's overall assessment. RESULTS:A total of 55 patients were included. The physician's overall assessment indicated that ~80% of patients who had CT added to ongoing pharmacotherapy were stable or improved. Mini-Mental State Examination scores also remained stable over 15 months of therapy (20.6 ± 3.0 at baseline and 20.1 ± 5.6 at follow-up, P = 0.5233, n = 27). Caregiver assessments indicated that most patients were stable or improved with respect to memory and ability to carry out activities of daily living. The most frequent adverse events with CT involved the gastrointestinal system. CONCLUSION:Results from this chart review indicate that addition of CT to pharmacotherapy was associated with stable disease or improvement over a follow-up period of 18.8 months.

SUBMITTER: Maynard SD

PROVIDER: S-EPMC3810439 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Retrospective cohort study of the efficacy of caprylic triglyceride in patients with mild-to-moderate alzheimer's disease.

Maynard Steven Douglas SD Gelblum Jeff J

Neuropsychiatric disease and treatment 20131023

<h4>Background</h4>The purpose of this study was to evaluate the effects of caprylic triglyceride (CT) in patients with mild-to-moderate Alzheimer's disease (AD) in routine clinical practice via review of medical records and caregiver questionnaires.<h4>Methods</h4>Participants were outpatients aged ≥50 years with a diagnosis of probable mild-to-moderate AD who had received CT for ≥6 months. The primary outcome was change from baseline in the patient's condition as rated by the treating physicia ...[more]

PMID: 24187497

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Project description:BackgroundAlterations in circadian rhythms are present in the presymptomatic stage of Alzheimer's disease (AD), possibly contributing to its pathogenesis. However, it is unknown whether such alterations are associated with worse outcomes once individuals are diagnosed with symptomatic disease. We aimed to evaluate the association between the circadian rest-activity pattern and AD-related features in patients with mild-moderate AD.MethodsWe assessed the circadian rest-activity pattern of consecutive patients with mild-moderate AD through actigraphy for 14 days. Cerebrospinal fluid was obtained to determine the levels of important pathological markers including amyloid-beta protein (Aβ42), phosphorylated tau (P-tau), total tau (T-tau), and neurofilament light (NF-L). Neuropsychological evaluation was conducted at the beginning of the study and after 12 months of follow-up. Linear regression models were performed considering the global population and Aβ42+ patients only.ResultsThe cohort included 100 patients with mild-moderate AD. The median age [p25;p75] was 76.0 [73.0;80.0] years and 63.0% were female. Older age (effect size [SE] of 0.324 [0.096]; p = 0.001) and male sex (0.780 [0.193]; p = 0.001) were associated with increased fragmentation and decreased synchronization of the rhythm, respectively. After adjusting for age, sex, and season of the year, increased levels of T-tau (effect size [95% CI] of 0.343 [0.139 to 0.547]; p = 0.001) and NF-L (0.444 [0.212 to 0.676]; p = 0.001) were associated with a higher amplitude of the rest-activity rhythm. Increased fragmentation of the rhythm at baseline was associated with greater cognitive decline after one year of follow-up independent of age, sex, T-tau/Aβ42 ratio, educational level, and season of the year (- 0.715 [- 1.272 to - 0.157]; p = 0.013). Similar findings were obtained considering only the Aβ42+ patients.ConclusionsOur results suggest a potential role of the circadian rest-activity pattern in predicting the cognitive decline of patients with mild-moderate AD. Further studies are warranted to confirm these findings and to elucidate whether there is causality among the observed associations.

Project description:BACKGROUND:Alzheimer's disease is characterized by the deposition of amyloid-beta (Aβ) plaques in the brain. Aβ is produced from the sequential cleavage of amyloid precursor protein by β-site amyloid precursor protein-cleaving enzyme 1 (BACE-1) followed by γ-secretase. Verubecestat is an oral BACE-1 inhibitor that reduces the Aβ level in the cerebrospinal fluid of patients with Alzheimer's disease. METHODS:We conducted a randomized, double-blind, placebo-controlled, 78-week trial to evaluate verubecestat at doses of 12 mg and 40 mg per day, as compared with placebo, in patients who had a clinical diagnosis of mild-to-moderate Alzheimer's disease. The coprimary outcomes were the change from baseline to week 78 in the score on the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog; scores range from 0 to 70, with higher scores indicating worse dementia) and in the score on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL; scores range from 0 to 78, with lower scores indicating worse function). RESULTS:A total of 1958 patients underwent randomization; 653 were randomly assigned to receive verubecestat at a dose of 12 mg per day (the 12-mg group), 652 to receive verubecestat at a dose of 40 mg per day (the 40-mg group), and 653 to receive matching placebo. The trial was terminated early for futility 50 months after onset, which was within 5 months before its scheduled completion, and after enrollment of the planned 1958 patients was complete. The estimated mean change from baseline to week 78 in the ADAS-cog score was 7.9 in the 12-mg group, 8.0 in the 40-mg group, and 7.7 in the placebo group (P=0.63 for the comparison between the 12-mg group and the placebo group and P=0.46 for the comparison between the 40-mg group and the placebo group). The estimated mean change from baseline to week 78 in the ADCS-ADL score was -8.4 in the 12-mg group, -8.2 in the 40-mg group, and -8.9 in the placebo group (P=0.49 for the comparison between the 12-mg group and the placebo group and P=0.32 for the comparison between the 40-mg group and the placebo group). Adverse events, including rash, falls and injuries, sleep disturbance, suicidal ideation, weight loss, and hair-color change, were more common in the verubecestat groups than in the placebo group. CONCLUSIONS:Verubecestat did not reduce cognitive or functional decline in patients with mild-to-moderate Alzheimer's disease and was associated with treatment-related adverse events. (Funded by Merck; ClinicalTrials.gov number, NCT01739348 .).

Dataset Information

Retrospective cohort study of the efficacy of caprylic triglyceride in patients with mild-to-moderate alzheimer's disease.

Publications

Retrospective cohort study of the efficacy of caprylic triglyceride in patients with mild-to-moderate alzheimer's disease.

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