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VANCOUVER, British Columbia, April 30, 2020 /PRNewswire/ -- Alpha Cognition Inc. (ACI) today announced that in apre-InvestigationalNew Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clinical and regulatory pathway for the approval of Alpha-1062, a patented new chemical entity, to treat Alzheimer's disease.The FDA has suggested that a single pivotal trial, scheduled for mid-2021, may be sufficient to obtain marketing approval.ACI also met with Japan's Pharmaceutical and Medical Devices Agency (PMDA) earlier this year, who also agreed to consider a similar pathway for approval in Japan. This follows an earlier press release announcingACI'spartnership withLinical, a Japanese-based contract research organization that will provide regulatory consulting and strategic development services, including post-marketing studies, for Alpha-1062 in Japan. ACI'sDirector of Regulatory Affairs,Mrs. Colleen Johns, commented that, "We are pleased with the responses we received from the FDA and the PMDA." She went on to say, "With the confirmation from the FDA that our suggested pathway is acceptable, we are well-positioned to progress the program quickly and efficiently to approval." Alpha-1062 is being developed in both an oral tablet and nasal spray format. Clinical trials have demonstrated that the intranasal formulation showed a decrease of over 90% in GI-related adverse events compared to an approvedAChEI(Razadyne) at similar dose levels. For additional information about the Company and its research programs, visit the Company's website athttp://www.alphacognition.com. About Alpha Cognition Inc. Alpha Cognition Inc. (ACI) is engaged in neurological disease research and has developed programs in Alzheimer's Disease andamyotrophiclateral sclerosis (ALS). Alpha-1062 is a patented new chemical entity that has shown efficacy inpreclinicaland recently completed human clinical trials.It is being developed as a new generationacetylcholineesteraseinhibitor (AChEI) with minimal gastrointestinalside effects and new routes of administration.Alpha-1062's active metabolites are differentiated fromdonepezilandrivastigminein that they may sensitize neuronalnicotinicreceptors, most notably the alpha-7 subtype, which may have a positive effect on the disease. Alpha-602 (Progranulin) is a natural protein that is expressed in several cell types in the central nervous system and in peripheral tissues. Alpha-602 regulates cell survival and certain inflammatory processes.The protein plays a major role in regulatinglysosomalfunction andmicroglialresponses.Its use in the treatment of ALS has been patented by ACI and is being investigated inpreclinicalmodels. For additional information about this press release contact:[emailprotected] For additional information about the company contact:[emailprotected] Or write to:Investor Relations Alpha Cognition Inc. 439HelmckenStreet, Vancouver, B.C. V6B 2E6 Related Images alpha-cognition.jpg Alpha Cognition SOURCE Alpha Cognition, Inc. Related Links http://www.alphacognition.com

Answer: Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy