Double-blind, placebo controlled study of acetyl-l-carnitine in patients with Alzheimer's dementia

1990 ◽  
Vol 11 (10) ◽  
pp. 638-647 ◽  
Author(s):  
G. Rai ◽  
G. Wright ◽  
L. Scott ◽  
B. Beston ◽  
J. Rest ◽  
...  
2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Simon Chiu ◽  
Nigel Gericke ◽  
Michel Farina-Woodbury ◽  
Vladimir Badmaev ◽  
Hana Raheb ◽  
...  

Introduction. Converging evidence suggests that PDE-4 (phosphodiesterase subtype 4) plays a crucial role in regulating cognition via the PDE-4-cAMP cascade signaling involving phosphorylated cAMP response element binding protein (CREB).Objective. The primary endpoint was to examine the neurocognitive effects of extractSceletium tortuosum(Zembrin) and to assess the safety and tolerability of Zembrin in cognitively healthy control subjects.Method. We chose the randomized double-blind placebo-controlled cross-over design in our study. We randomized normal healthy subjects (totaln=21) to receive either 25 mg capsule Zembrin or placebo capsule once daily for 3 weeks, in a randomized placebo-controlled 3-week cross-over design. We administered battery of neuropsychological tests: CNS Vital Signs and Hamilton depression rating scale (HAM-D) at baseline and regular intervals and monitored side effects with treatment emergent adverse events scale.Results. 21 subjects (mean age: 54.6 years ± 6.0 yrs; male/female ratio: 9/12) entered the study. Zembrin at 25 mg daily dosage significantly improved cognitive set flexibility (P<0.032) and executive function (P<0.022), compared with the placebo group. Positive changes in mood and sleep were found. Zembrin was well tolerated.Conclusion. The promising cognitive enhancing effects of Zembrin likely implicate the PDE-4-cAMP-CREB cascade, a novel drug target in the potential treatment of early Alzheimer’s dementia. This trial is registered with ClinicalTrials.govNCT01805518.


PLoS ONE ◽  
2012 ◽  
Vol 7 (5) ◽  
pp. e35185 ◽  
Author(s):  
Chris Fox ◽  
Monica Crugel ◽  
Ian Maidment ◽  
Bjorn Henrik Auestad ◽  
Simon Coulton ◽  
...  

Healthcare ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1678
Author(s):  
Charlotte Kloft ◽  
Robert Hoerr

Following reports of bleeding upon Ginkgo intake, we assessed whether Ginkgo extract EGb 761® affects coagulation or platelet function or increases the risk of bleeding. In a double-blind, placebo-controlled trial, prothrombin time, activated partial thromboplastin time, international normalized ratio and bleeding time were measured in patients with Alzheimer’s dementia at baseline, weeks 6 and 26. A total of 513 patients were randomized to 120 mg (n = 169) or 240 mg EGb 761® (n = 170) or placebo (n = 174). No relevant changes were found for coagulation parameters and bleeding time. Numbers of bleeding-related adverse events were similar in all groups. Concomitant intake of acetylsalicylic acid was documented for 68 patients in the placebo group and 105 in the EGb 761® groups. Within these groups, the means at baseline and week 26 differed by less than 1 unit for prothrombin time and bleeding time and less than 0.1 unit for international normalized ratio. Data on warfarin treatment in nine patients each taking placebo or EGb 761® did not indicate enhancement of warfarin effects by EGb 761®. No evidence was found that EGb 761® affects hemostasis or increases the bleeding risk. No pharmacodynamic interactions with warfarin or acetylsalicylic acid were found.


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