CHARLOTTETOWN, Prince Edward Island--(BUSINESS WIRE)--Neurodyn Life Sciences Inc. announced completion of its first-in-human clinical study, demonstrating Memogain’s potential benefits over existing Alzheimer’s drugs;
- increased safety in the absence of significant side effects,
- more potent cognitive enhancement.
The Phase IA clinical trial addressed safety, tolerability, and pharmacokinetics of intranasally delivered Memogain® in healthy young and elderly subjects, compared to the daily recommended doses of the current Alzheimer’s drugs: galantamine (16 mg) and donepezil (10 mg). Study participants were additionally tested for improved cognition.
The administration of Memogain® was found to be safe and well tolerated at all dose levels. No clinical abnormalities were seen in hematology, blood chemistry, urine analysis, ECG or vital signs. Adverse events were either mild or moderate. The most prevalent being nausea, reported by a few subjects administered the standard galantamine dose of 16 mg, but only observed at the highest Memogain® dose (44mg). The excellent safety and tolerability of Memogain®, will dispense with the month-long gradual dosage increase that presently is common practice for other Alzheimer’s drugs, permitting the immediate administration of an efficacious dose.
“This outstanding safety and tolerability profile is achieved even though Memogain®, a prodrug of galantamine, has a 10 times higher concentration in the brain, as compared to orally administered galantamine,” says Dr. Maelicke, Memogain’s developer. “Additionally, Memogain® has a delayed release profile which could facilitate single daily dosing.”
In cognitive testing, Memogain® was able to improve vigilance and short-term memory capacity: eye-hand coordination and vigilance was measured in the adaptive tracking test, and word learning and recall in the visual verbal learning test (VVLT). Both young and elderly subjects performed better than untreated volunteers in these tests. Galantamine, failed to show improvement in either the adaptive tracking test, or the VVLT, where donepezil also failed to demonstrate improvement.
Earlier preclinical studies have demonstrated Memogain’s potential to provide neuroprotection and delay disease progression. Should future clinical studies also substantiate these findings, Memogain® may become the urgently needed turning point in the treatment of Alzheimer’s and other neurodegenerative diseases such as Parkinson’s disease.
