Alzheimer’s disease is a complex illness with many contributing factors, therefore requiring a multimodal treatment approach. The standard of care offers single treatment modalities for a specific pathological driver. Precision medicine relies on diagnostics and personalized recommendations rather than a one-size-fits-all approach. A precision medicine approach is better suited for addressing complex chronic disease by assessing and treating multiple pathological contributors.
As a follow-up to a successful pilot project using a precision medicine approach, a randomized controlled trial shows that precision medicine represents an effective treatment for early-stage dementia due to Alzheimer’s disease.
The Study
A randomized controlled trial preprint awaiting peer review reveals that a precision medicine approach leads to cognitive improvement rather than merely retarding decline. Seventy-three patients aged 45-76 with mild cognitive impairment or early dementia were randomized to receive a 9-month personalized, precision medicine protocol or standard of care treatment. Patients underwent a comprehensive evaluation, including diagnostic markers, cognitive testing, and imaging.
Precision medicine program treatments and evaluations included:
- Diet: Ketogenic, low glycemic, plant-focused, organic, gluten-free, dairy-free, minimally processed, with a 12-16 hour overnight fast. Blood ketone levels were monitored via fingerstick daily.
- Exercise: 45 minutes per day, 6 days per week, aerobic exercise, and twice weekly strength training. Personal trainers facilitated exercise programs.
- Sleep: 7-8 hours per night tracked by Oura ring. Home sleep studies identified those patients requiring continuous positive airway pressure (CPAP) apparatus or a dental splint device to improve oxygenation.
- Stress management: 10 minutes daily of HeartMath or biofeedback
- Brain training: Minimum 15 minutes daily of BrainHQ, an online cognitive training program
- Hormones and nutrients: For those with suboptimal levels, prescriptions included bioidentical hormone therapy (sex hormones), neurosteroids (dehydroepiandrosterone, pregnenolone), thyroid medications, and nutrients (vitamin D, omega-3, B vitamins, CoQ10, or minerals).
- Gastrointestinal health: Stool testing that identified inflammation, digestive insufficiency, and imbalances in gastrointestinal microbes was supported with gut-healing nutrients, dietary restriction, digestive enzymes, and microbiome support.
- Inflammation: Systemic inflammation was assessed with C-reactive protein, fibrinogen, homocysteine, and autoimmune markers. Treatments included specialized pro-resolving mediators and anti-inflammatory herbal supplements (liposomal glutathione, fish oil, turmeric, resveratrol, vitamins C and D, Boswellia, and quercetin), and low-dose naltrexone was prescribed for autoimmunity.
- Infectious agents: Testing and treatment for Herpes simplex infection or a history of outbreaks, active Epstein-Barr Virus (EBV), and tick-borne infections such as Borrelia, Babesia, or Bartonella.
- Toxins and toxicants: Testing and treatment for metals, organic pollutants, and biotoxins included binding agents, sauna, herbs, sulforaphane, and dietary restriction of seafood if indicated.
- Photobiomodulation: Low-level light therapy or near-infrared light therapy has cognitive benefits.
- Adjunctive therapies: Certain study sites included additional therapies like hyperbaric oxygen, exercise with oxygen therapy, cranio-electrical stimulation, or neurofeedback.
Compared to the standard of care, the precision medicine group experienced greater improvements in memory scores, executive function scores, overall cognitive indices, processing speed, cognitive symptoms, partner-judged cognitive status (AQ change), brain training scores (BrainHQ), and epigenetic profiles. Precision medicine demonstrated a substantially larger effect on overall cognitive function than previously reported trials—approximately seven times greater than lecanemab and four times greater than donanemab—without the negative side effects.
The metabolic benefits were also significant. Compared to the standard of care, the precision medicine group displayed a statistically significant reduction in body mass index, systolic blood pressure, diastolic blood pressure, glycation (reduced hemoglobin A1c), and insulin resistance (HOMA-IR, homeostasis model assessment-estimated insulin resistance). Improvements were also observed in lipid profiles, methylation (reduced homocysteine), as well as a significant increase in serum vitamin D.
Conclusions
In this trial, personalized, precision medicine demonstrates that treating the whole person leads to optimal outcomes for cognitive and overall health. This is compared to a monotherapeutic approach, which currently serves as the standard of care.
