The study will be led by Professor Ralph Martins, PhD, a recognized leader in Alzheimer’s research, at the Centre of Excellence for Alzheimer’s Disease Research and Care, Edith Cowan University in Perth, Australia, where Dr. Martins has served as head of the Sir James McCusker Unit for Alzheimer’s Disease Research for more than 20 years.
Known for his part in successfully isolating beta amyloid protein responsible for forming the amyloid plaque deposits in the brain—a characteristic diagnostic feature of Alzheimer’s disease—Dr. Martins later went onto demonstrate that the Alzheimer’s brain is under oxidative stress, which is now recognized to mediate the action of beta amyloid to cause Alzheimer's. He is also working to develop an early diagnostic blood test to effectively prevent and/or treat this devastating degenerative brain disease.
Curcumin studies in animal models of Alzheimer's have demonstrated that it can play a significant role in the destruction of beta amyloid plaque. It is also a powerful antioxidant, with an ORAC value of 159,277 per 100 gm, as determined by the United States Department of Agriculture (USDA). Other studies have shown that curcumin plays a role in neuronal regeneration.
In the past studies however, there have been significant problems with curcumin absorption and as a result, clinical work with plain curcumin has required very high dosing. To that end, the type of curcumin to be used in Dr. Martins’ study will be a special bioavailable form of curcumin called BCM-95, which is exclusively distributed as CuraMedin the US by EuroPharma.
“I chose BCM-95 curcumin for this human study because it has published human bioavailability data,” explained Dr. Martins in a press release. “Therefore, I can use a reasonable amount and expect that the serum levels will achieve a therapeutic range for a significant period of time.”
Researchers are currently recruiting participants with mild cognitive impairment (MCI) to be followed for 12 months, with periodic assessment of brain function and memory, as well as blood and cerebrospinal fluid biomarkers. One group of participants will be dosed with three 500 mg BCM-95 curcumin twice daily. There will also be a placebo group. The completion of the study is projected to be June 2013.
Cheryl Myers, who is chief of scientific affairs at EuroPharma and will be working closely with Dr. Martins through the course of the study, told Nutraceuticals World that there are two goals set for this study. “The first hypothesis to prove is that it is expected that BCM-95 curcumin will significantly slow the progression of dementia,” she said. “The second is that there will be a significant change in blood biomarkers having to do with destruction of beta amyloid proteins that form plaque on the brain.”
Curcumin’s Connection to Alzheimer's
Researchers hope the design of their study will enable them to tap into curcumin’s powerful antioxidant and anti-inflammatory properties. “Curcumin is a super-potent antioxidant (ORAC value is 159,277 per 100 grams. By comparison, blueberries are a bit over 8,000 per 100 grams),” said Ms. Myers. “It has been proven that the Alzheimer’s brain is under inordinate amounts of oxidative stress, which is partly neutralized by potent antioxidants.”
She also highlighted curcumin’s powerful anti-inflammatory properties. “Curcumin addresses inflammation by modulating several inflammation pathways in the body, as opposed to prescription and OTC drugs, which generally address only one pathway,” she said. “Individuals with higher levels of systemic inflammation are at higher risk for Alzheimer's and it has been shown that there are inflammatory characteristics in the development of the disease.”
Ms. Myers said one of the most exciting scientific findings of the past 50 years is the discovery that certain brain regions make new neurons (brain cells) throughout life and added that curcumin has been shown to actively support the process of creation of new brain cells, a process called neurogenesis.
The hippocampus region of the brain, associated with learning and memory functions, is a major site of adult neurogenesis, and is also the structure affected in various neurologic diseases.”Scientific evidence suggests that adult neurogenesis is important in neurologic disorders such as Alzheimer's, because hippocampal structure and function are dysregulated in this disorder,” explained Ms. Myers. “Yet another way in which curcumin may address Alzheimer's is the destruction of beta amyloid plaque, a structural feature of advancing Alzheimer's in which abnormal protein deposits accumulate in the brain that further disrupts cell to cell communication and disrupts thinking.
“In a mouse model of Alzheimer's there was a 30% regression in beta amyloid plaque brain deposits after only seven days of curcumin administration,” she continued. “Therefore, curcumin is perfectly suited for studies on Alzheimer's as it effectively addresses so many aspects of the disease simultaneously.”