AUSTIN, Texas--(BUSINESS WIRE)--As the field of cognitive care expands, the aging global population is bringing heightened attention to neurodegenerative diseases like Alzheimer's and other forms of dementia. IntellxxDNA™ stands as a leader, offering actionable genomic insights that can help prevent and reverse the symptoms of cognitive decline through precision genomic medicine. Signifying a new era in cognitive health research, IntellxxDNA™ is proud to announce its IRB approval for the GPS-MEM Study: A Precision Study of Memory. This study will offer cutting-edge genomic insights and personalized intervention strategies for each participant.
The study will evaluate the efficacy of IntellxxDNA's clinical decision support (CDS) tool. This tool assists in identifying modifiable factors contributing to cognitive decline and other potentially related chronic conditions. IntellxxDNA’s clinical decision support tool also aims to support physicians in developing a genomically targeted personalized plan for addressing the modifiable contributing factors in individuals with mild cognitive impairment or early dementia.
A secondary objective is to determine the proportion of individuals benefiting from this approach and to assess typical improvements in cognitive outcomes. The final goal is to gather feedback from medical practitioners on how significantly the IntellxxDNA™ genomics tool influenced and aided their decision-making process.
While Dr. Sharon Hausman-Cohen, the medical director of IntellxxDNA™, played a pivotal role in designing the study, clinical decisions will be made by the patients' physicians—namely, primary investigators Dr. Anne Stefani and Dr. Sandeep Kapoor. Both are published doctors in this field. Doctors who have used IntellxxDNA™ have reported significant success in treating patients with cognitive decline. They have been instrumental in reversing symptoms, paving the way for breakthroughs in cognitive care.
This genomically-targeted trial, aiming at memory improvement, will enroll up to 20 patients with dementia or mild cognitive impairment (MCI). The study's inclusion criteria are:
- Participants must provide consent.
- Participants should be between 50 and 85 years of age and exhibit symptoms of Subjective Cognitive Impairment (SCI), MCI, or early dementia as defined by a MOCA score ranging from 15 to 26.
- Participants must have had a baseline Mini-Mental State Examination (MMSE) score of 24-30.
Clinical Dementia Rating-Sum of Boxes (CDR-SB) global scores will be tracked, with a score of 0.5 being typical for inclusion. This tracking enables a comparison to the aducanumab study. (Physicians are currently undergoing training on this aspect.) CNS vitals memory scores will be observed for additional data.
Dr. Sharon Hausman-Cohen stated, "The fusion of genomics and clinical decision-making offers a frontier of hope. With the GPS-MEM study, we're not just observing; we're aiming to change the narrative of cognitive health. Our deep genetic insights paired with actionable intervention strategies have the potential to redefine memory care." The team at IntellxxDNA™ is energized by the momentum this IRB approval brings. As they set forth on this journey, their ambition is clear: to advance patient care, armed with the precision and promise that only genomics can provide.
IntellxxDNA™ is at the forefront of genomics intelligence, dedicated to revolutionizing personalized medicine. They equip functional and integrative clinicians with deep molecular insights into their patients, enabling evidence-based, precision treatments. Their mission goes beyond individual healing, aiming to usher in a new era of care for individuals.
The study obtained IRB approval on August 16, 2023, with Protocol Number INT-MEM-101 and Approval Number: IRCM-2023-376.