scholarly journals Efficacy and Blood Plasmalogen Changes by Oral Administration of Plasmalogen in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

EBioMedicine ◽  
2017 ◽  
Vol 17 ◽  
pp. 199-205 ◽  
Author(s):  
Takehiko Fujino ◽  
Tatsuo Yamada ◽  
Takashi Asada ◽  
Yoshio Tsuboi ◽  
Chikako Wakana ◽  
...  
2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014


2017 ◽  
Vol 12 (4) ◽  
pp. 268-285 ◽  
Author(s):  
Nathalie E. Marchand ◽  
Majken K. Jensen

Concern over loss of cognitive function, including descent into Alzheimer’s disease or dementia, grips a growing percentage of men and women worldwide as the global population ages. Many studies, though not all, suggest that maintaining cognitive health, as well as slowing and even preventing cognitive decline, dementia, and Alzheimer’s disease, can be achieved by consuming healthy diets over a long enough period of time. This appears to be the case even for those who initiated dietary changes later in life, as evidenced by an intervention study assessing consumption of a healthy diet among those who were >50 years of age. All such diets share the common traits of being rich in fruits, vegetables, whole grains, and fish or seafood, while also being low in red meat and sweets. A Mediterranean-style diet shares these characteristics and has been associated with an estimated 40% lower risk of cognitive impairment, including mild cognitive impairment, dementia, and Alzheimer’s disease in prospective studies, in addition to being associated with both a 65% lower risk of mild cognitive impairment and improved cognitive performance in a notable randomized controlled trial.


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