Comparing the efficacy and safety ofCrocus sativusL. with memantine in patients with moderate to severe Alzheimer's disease: a double-blind randomized clinical trial

2014 ◽  
Vol 29 (4) ◽  
pp. 351-359 ◽  
Author(s):  
Mehdi Farokhnia ◽  
Mehdi Shafiee Sabet ◽  
Negar Iranpour ◽  
Amirhossein Gougol ◽  
Habibeh Yekehtaz ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind

scholarly journals P1-244: Combined treatment with cerebrolysin and donepezil in mild to moderate alzheimer's disease: Results of a double-blind, randomized clinical trial

2009 ◽  
Vol 5 (4S_Part_8) ◽  
pp. P248-P248
Author(s):  
Anton Alvarez ◽  
Ramon Cacabelos ◽  
Manuel Aleixandre ◽  
Carlos Linares ◽  
Elias Granizo ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Combined Treatment ◽  
Double Blind

P3-448: Neurotrophic and cholinergic treatment in Alzheimer's disease: Results of a randomized clinical trial

2010 ◽  
Vol 6 ◽  
pp. S585-S585
Author(s):  
Anton Alvarez ◽  
Carolina Sampedro ◽  
Veronica Couceiro ◽  
Ramon Cacabelos ◽  
Manuel Aleixandre ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Randomized Clinical Trial

scholarly journals A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

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

scholarly journals Correction to: Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial

2019 ◽  
Vol 18 (2) ◽  
pp. 583-583
Author(s):  
Khojasteh Joharchi ◽  
Moosareza Memari ◽  
Eznollah Azargashb ◽  
Navid Saadat
Keyword(s):  
Clinical Trial ◽  
Neuropathic Pain ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Iranian Patients

The article Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial, written by Khojasteh Joharchi, Moosareza Memari, Eznollah Azargashb, and Navid Saadat, was originally published.

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