To Increase the Economical Value Of the Brain Up-10 Technology In Order To Strengthen the Technology Transfer Process By Developing a Set Of Advanced R&d Activities Including An Advanced Phase Ii Clinical Trial the Standarization Of the Natural Compound Together With Its Molecular Characterization And the Establishment Of Gmp Condition For Its Extraction. Specific Objectives1. To Carry Out a Phase Ii Study In Two Countries In Order To Validate the Effectiveness Of the Formula Brain Up-10. 2. To Develop a Standardization Of the Natural Product Brainup-10 And To Determine the Molecular Characterization Of the Different Component Of This Natural Product To Establish the Fingerprint Of This Natural Component Endemic From the North Of Chile. 3. To Certify According With International Protocols That the Extraction Procedure As Well As Production Of This Natural Product Follows All Gmp Standards. 4. To Carry Out Activities Of Technology Transfer In Order To Commercialize the Patent Already Obtained In Three Different Countries Or To Negotiate the License Of the Technology To a Large Nutraceuticals Or a Pharmaceutical Company.Alzheimer´s Disease (ad) is Impacting the Elderly In U. S. A. At An Alarming Rate Estimates Suggest a Prevalence Of 36 Million Worldwide. This May Double By 2030 Unless Effective Interventions Can Be Developed. With the Increase In Life Expectancy Ad Has Become a Public Health Priority. Accepted Therapies In Ad Have Only Symptomatic Effects And As Today We Do Not Have Any Drug That Stop Pathophysiological Processes Leading To Neurodegeneration. The Primary Causes Of Ad Are Still Unknown And Probably Involve a Complex Interrelation Of Genetic And Environmental Factors Diminishing the Possibilities For Developing Specific New Drugs. Fortunately We Have Improved Our Knowledge Of Key Pathophysiological Events Of Ad And Have Focused Our Attention On Tau Aggregates As a Real Target For New Anti-alzheimer Compounds. Our Team At the International Center For Biomedicine (icc) With More Than 30 Years Of Successful Research In the Field Has Found That a Formula Based On B Complex Vitamins And the Andean Complex (brainup-10) a Unique Phytocompound Obtained From Chilean Andes And Originated By Ancient Mechanisms Of Plant Decomposition Improves Cognitive Performance. In This Project We Will Carry Out Adnaved Research To Validate This Nutraceutic Technology And Carry Out Studies For Standarization Of the Natural Compound. This Nutraceutical Appears To Be Effective In Controlling Cognitive Disorders. This Seems To Be a Very Attractive Therapeutic Alternative Since Brainup-10 May Act At Multiple Molecular Targets Of Ad. In This Context We Have Found That Brainup-10 Inhibit Tau Molecules Aggregation In Vitro so It May Be a Good Candidate For An Ad Therapy. We Carried Out Studies That Show No Toxicity In Animals And We Have Also Evaluated the Brainup-10 In Healthy Volunteers (phase 1 Study) Demonstrating a Wide Range Of Biological Safety. We Have Also Carried Out a Pilot Placebo-controlled Randomized Study In Ad Patients. Patients Treated With Brainup-10 Exhibited Significantly Lower Levels Of Peripheral Biomarkers Of Ad And Also a Tendency To Perform Better In the Clinical Tests Than Placebo Subjects. Studies Indicate That Brainup-10 is Useful For the Prevention And Possibly As a Coadjuvant For the Treatment Of Ad. We Have Considered the Necessity Of Running a Phase Ii Clinical Trial. We Will Carry Out a Phase Ii Clinical Trial In Order To Evaluate the Effectiveness Of Brainup-10 Cognitive Actions Within the Framework Of Innova Guidelines. A Cohort Of 95 Subjects (60 In U. S. A. And 35 In Chile) Will Be Evaluated Clinically As Well As Their Cognitive Status During One Year. One Group (n=50) Will Be Treated With Brainup-10 While Another Group (n=45) With Placebo. As a Second Objective We Will In Parallel Standarize the Natural Compound In Order To Define Its Molecular Components And the Biological Actions Of the Isolated Fractions Separated By Chromatographic Tools so To Develop Into a More Effective Treatment For Ad. Moreover We Will Establish the Extraction Procedures According With Gmp International Standards. These Objectives Will Allow To Significantly Increase the Scientific Strengths And In Turn the Economic Value Of This Technology And Define the Ways To Turn This Nutraceutical In a Pharmaceutical Product Against Alzheimer´s Disease Whose Value In a Technology Transfer Process Will Increase In a Large Proportion. Funds From the Innova Will Be Critical To Perform a Complete And Rigorous Evaluation On the Efficacy Of Brainup-10 As a Reliable Compound For the Treatment And Prevention Of Ad And To Standarize the Compound From the Molecular And Biological Points Of View.Corporación de Fomento de la Producción