Alzheimer’s Gene Therapy Human Study Seeks Volunteers

14 October 2019

Integrated Health Systems, in partnership with Maximum Life Foundation, is funding a trial to rejuvenate microglial cells using telomerase gene therapy. This trial is currently looking for ten patients with mild to moderate Alzheimer’s Disease. At this time five of the positions have been filled. The trial will be conducted in MONTEREY, Mexico. Treatment is free to participants.

We are proud to announce that Maximum Life foundation has recently received a forty thousand ($40,000) dollar donation to make projects like this come to fruition!  

The Sound of Music  

Music is universally loved, including by those affected by dementia. New research shows playing music familiar to Alzheimer’s patients can help them manage their symptoms and improve their quality of life. Although it is not a cure, music can increase functional connectivity in brain networks. 

This can help patients fight through the haze of their disease and regain some clarity. Familiar music generate an ASMR, an  “autonomous sensory meridian response.” These sort of audio clips can make us sit up in joy or calm us down. What exactly it triggers, we don’t know, but perhaps music can take us back to healthier days and forward again.

Henry has dementia, but comes alive when he hears songs from his youth. 

Alzheimer’s Disease: When Your Brain is Clogged Up

Maintenance is a key – to keep a machine running  it has to be kept well-oiled. All its small parts need to be in shape, they need to be able to receive supplies, store information, and get rid of waste. 

Our brain is not any different. It is nothing but a giant communication network made up of billions of neurons (nerve cells). But Alzheimer’s Disease (AZD) breaks down our brain bit by bit, wreaking havoc on our memory, behavior, and cognitive abilities. Two kinds of proteins in our brain,  tau and amyloid, are actors in this debilitating disease. The tau proteins in your brain could be tangling up or the amyloid proteins might be clumping together into “plaques”, leading to problems in how remembering things or performing day-to-day activities. Some tangles and plaques are normal as we age, but the brains of those affected by Alzheimer’s Disease form many more in predictable patterns. 

Why does this happen? It is believed the cells that help keep the brain clean, called microglial cells, become less functional with time.  

So, is there anything medical science can do to make these microglial cells work again? Nothing has been proven yet, but there are some promising options on the horizon. 

Who is at Risk?

In America, more than 5.7 million people have Alzheimer’s Disease (about 44 million worldwide). While there are several types of dementia, Alzheimer’s is the most common. Someone develops dementia every three seconds and though not all of these are AZD, the majority are – AZD accounts for 60 – 80% of all dementia cases, which includes 11% of those aged 65 and older and one third of those 85 and older. 

Age, lifestyle, and genetics are all risk factors. While these genes do not confirm that one will definitely get the disease, it lends an increased risk. 

New research is also beginning to show that there might be a link between serious head injury and AZD. Although this might sound like common sense, there is an increasing amount of evidence that holistic, healthy aging – healthy, clean eating, regular, moderate exercise, avoiding excessive tobacco and alcohol use, and an active social life –  keeps our bodies and brains healthy and possibly reduce the risk of developing Alzheimer’s.  

New clinical trials are also finding new pathways towards eliminating Alzheimer’s Disease. For example: Integrated Health System, in partnership with Maximum Life Foundation, is funding a trial to rejuvenate microglial cells using telomerase gene therapy. This trial is currently recruiting ten patients with mild to moderate Alzheimer’s Disease. The trial will be conducted at the Williams Cancer Institute in Monterey, Mexico. The treatment is free to trial participants, but they will have to pay for their travel costs to the trial center, and for tests that are required for assessing their disease condition.

Next up: What do we know about AZD and what steps can we take in case of a diagnosis…

Alzheimer’s Disease: What Do We Know?

An Alzheimer’s diagnosis can be a heart-wrenching and tumultuous time. Being told you have a terminal condition without a cure and limited treatment options is life altering for patients and their families. 

Science has definitely come a long way. However, we  only know a tiny fraction of what goes on in our central nervous system. While we sometimes don’t have a cure, we often have preventative measures. But prevention is shrouded in mystery when it comes to Alzheimer’s Disease. Though we might not have clear-cut answers, we do know that some lifestyle changes can prevent or delay AZD, though none of them can cure it. Lifestyle choices are also modulated by our individual risk factors.

For instance, there is an encouraging association between increased physical activity, blood pressure control, and cognitive training (activities designed to enhance memory, reasoning, and speed of processing) and a decreased risk of developing dementia. Meanwhile, diets were found to have a limited effect. 

Scientists are trying to understand the factors that contribute to the accumulation of amyloid plaques and, with these insights, nip it in the bud before it begins causing problems. Until this is possible, leading a physically, mentally, and socially active life is your best bet.  

How Do We Know When a Family Member Has Alzheimer’s? 

“Getting old” strikes fear at the heart of most of us. We are badgered by images of decrepit bodies, unclear and foggy minds – we envision ourselves as shells of the people we once were. And before us, come our parents, whom we watch as they age and develop age-related ailments. In such cases, it is critical to have a correct diagnosis of what exactly they and we need to prepare for. 

The diagnosis for Alzheimer’s is not straight forward, nor is it always clear. The disease is a “form” of dementia and has many symptoms that are similar to other forms of dementia. Common early signs of Alzheimer’s include:

  • Memory impairment,

  • Difficulty concentrating or solving problems 

  • Issues  finishing daily tasks at home or work

  • Confusion with location or passage of time

  • Having difficulties with spatial reasoning, such as not understanding distance in driving, getting lost, or misplacing items

  • Language problems, such as word-finding problems or reduced vocabulary in speech or writing

  • Using poor judgment in decisions

  • Withdrawal from work events or social engagements

  • Changes in mood, such as depression or other behavior and personality changes

This is not an exhaustive list, but if you’re concerned about a loved one, it is prudent to consult a physician. Further on, you might need consultations with neurologists or geriatricians who will administer more tests to confirm the initial diagnosis.   

It is critical to be prepared for the future.  

What is Alzheimer’s Gene Therapy?

When part of our car stops working, we repair or replace the part. The same goes for our genes. 

Replacing a dead battery is easy enough, but how do we do the same with our genome? How do we reach the cells to introduce a normal copy of the gene? 

It is done through a vector, vehicles that carry a desired gene. The carrier can be injected or given intravenously. It can be given systemically or to an organ of interest.   

Why This Matters

Integrated Health System’s gene therapy targets neurodegeneration in Alzheimer’s Disease. It will be using an adeno-associated virus (AAV) vector that has been modified for enhanced delivery to neural tissue. AAV gene therapies have been tested in humans with great success and there has been no evidence of adverse effects. At this time over 372 gene therapy trials are underway. 

How will it enter the patients’ bodies? IHS’s AAV telomerase gene therapy will be delivered via intrathecal injection into the cerebrospinal fluid (into the spine). 

Contact us to know more about this clinical trial or to sign up!

Why Focus on Telomerase? 

Simply put, because research is beginning to focus on the role of telomerase in the aging process, thereby improving regeneration and halting the progress of Alzheimer’s Disease. Telomeres are the short ends of our chromosomes that get shorter as we age. Telomerase is an enzyme that can extend these ends back again and rejuvenate the cells. 

We expect that by extending the telomeres of microglial cells, which are instrumental in Alzheimer’s Disease, we can arrest its progress. 

So, what do you need to know about our clinical trial?

  • We intend to test telomerase gene therapy to rejuvenate microglial cells in an Alzheimer’s Disease trial, building on already promising research study data. Telomerase gene therapy will be available to those diagnosed with mild to moderate Alzheimer’s Disease. 

  • The cost of the treatment is free to trial participants, but travel costs will not be covered. Neither will the assessments before and after treatment. Please contact us to learn more!

Who is Eligible and Why?

Positions are limited. We have only five remaining! There are a few prerequisites: 

 

Eligibility:  

  • 50 Years and older  

  • Any gender

  • No healthy volunteers please

Inclusion Criteria:

  • Probable Alzheimer’s Disease based on the diagnosis criteria of the U.S. National Institute on Aging and Alzheimer’s Association guideline

  • Male or female, 50 years and older 

  • All patients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group

  • Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures

  • Provide the informed consent

Exclusion Criteria:

  • Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination

  • Patients with mental illness

  • Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment

  • Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency)

  • Subjects who are unwilling or unable to abide by the study requirement

If you think you’re eligible and would like to know more, contact us… 

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