Adeona Pharmaceuticals, Inc., (Amex: AEN) announced completion of 100% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).
Part 2 of the CopperProof-2 study is designed as a 60-subject comparator study. Alzheimer's disease and mild cognitive impairment subjects are randomized on a 50:50 basis to receive either Zinthionein or matching placebo. After 3 and 6 months on clinical trial material, serum measurements of zinc and copper are taken and any changes in cognitive function using standard Alzheimer's disease clinical tests are recorded. Further information on the clinical study is available at http://www.clinicaltrials.gov/ct2/show/NCT01099332.
Zinthionein is Adeona's single dose, proprietary, gastro-retentive, sustained-release, oral formulation of zinc cysteine that is intended to have greater bioavailability of zinc than the FDA-approved preparation of inorganic zinc acetate. In addition, Zinthionein is designed to be better tolerated with significantly less gastrointestinal side effects than the FDA-approved preparation of inorganic zinc acetate.
Adeona expects that Part 2 of the CopperProof-2 study should be completed by the end of March 2011. To date, there have been no significant adverse effects seen and no dropouts of study participants. If successful, Adeona would expect to make commercially available its Zinthionein product as a prescription medical food for Alzheimer's disease and mild cognitive impairment patients.
David A. Newsome, M.D., F.A.R.V.O., Adeona's Senior Vice-President for Research and Development, remarked, "I am excited about the progress being made in this clinical study and obtaining in March the results of the first controlled clinical study of zinc and cysteine therapy in Alzheimer's disease and mild cognitive impairment subjects."
"Reaching this important milestone now allows us to focus on GMP production, product packaging and other Zinthionein-related pre-commercialization activities so that this product can expeditiously be made available to people with Alzheimer's disease and mild cognitive impairment after a positive study result." stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer.
Background of the CopperProof-2 Clinical Study and Zinc Therapy for Alzheimer's Disease and Mild Cognitive Impairment
Observations by Adeona scientists and other scientists of sub-clinical zinc deficiency in Alzheimer's disease patients plus a body of published literature that chronic elevated copper exposure contributes to the progression of Alzheimer's disease and mild cognitive impairment prompted the present CopperProof-2 clinical study. A small and uncontrolled zinc therapy study in Alzheimer's disease patients published in 1992 demonstrated cognitive improvements in 80% of subjects. In some subjects, the improvement was detectable after only 3 months of administering injectable zinc.
Alzheimer's disease can affect the entire brain but it is particularly associated with loss of tissue in the hippocampus, the area in the brain responsible for several functions including short-term memory retention and processing. The hippocampus has one of the highest concentrations of zinc in the brain. Hippocampal zinc is thought to play a role in hundreds of protective enzymes and other systems, including those that detoxify amyloid beta, an abnormally folded peptide that accumulates in aging and is a biomarker for Alzheimer's disease. When cerebrospinal fluid zinc is low, levels of the particularly toxic beta amyloid 42 are elevated.
Hippocampal zinc serves as a neurotransmitter, and also modulates a specific excitatory neuroreceptor, the NMDA (N-methyl-D-aspartic acid) receptor. If the neuroexcitation goes uncontrolled, there is a derangement of brain tissue function, and possibly neuronal death.By elevating cerebrospinal fluid zinc, NMDA receptor excitation may be better controlled, improving tissue function and thereby acute cognition and tissue survival, as may have been seen in the 1992 study. NMDA-receptor antagonists now available for Alzheimer's, including Namenda and Axura, annually sell an estimated $2.6 billion.
SOURCE Adeona Pharmaceuticals, Inc.