MIND Protocol Study: Optimizing Function in Alzheimer's Disease and Other Types of Dementia

Study by Jacob Teitelbaum, M.D.

[Study findings below reported by Denise Haire, Study Coordinator]

Plan

Use of a comprehensive approach to thoroughly evaluate and treat various types of dementia. This included a combination of supplements and prescription medications when necessary.

Objective

To determine whether or not treating the factors shown to contribute to Alzheimer's would result in cognitive and functional improvements. Subjective reporting of outcomes by study participants and their families, along with pre- and post-study assessments were conducted to measure any changes in cognitive or functional abilities.

The Protocol

The MIND study allowed us to evaluate a comprehensive mix of issues known to contribute to Alzheimer's Disease and other dementias, including the role of metabolic/hormonal function, underlying infections, nutritional support, and the role of drugs (medications) that can contribute to cognitive impairments and mimic or even worsen Alzheimer's Disease.

Initial Impressions

Upon initial evaluation we commonly saw that Alzheimer's Disease was being diagnosed with little to no proper work up for underlying contributing or exacerbating factors, even for patients who had been seen by neurologists across the country. We also saw that standard treatment was generally limited to the use of medications such as Aricept and Namenda.

Treatments

Research has shown that multiple nutritional deficiencies play a key role in increasing Alzheimer risk, so our protocol included nutritional supplements to support these needs. This included vitamins, minerals and herbal remedies including the Energy Revitalization System Vitamin Powder, fish oil (Vectomega), vitamin D and a special highly absorbed form of curcumin (CuraMed). Many people had symptoms suggesting the need for a trial of thyroid treatment, despite often having normal lab results. Symptoms also often suggested yeast/Candida overgrowth, often from years of antibiotic use. Poor sleep needed to be addressed in most participants with the use of natural sleep aids as a first line approach. Elevated Homocysteine levels were also common. Homocysteine is an amino acid that is produced during protein metabolism. High levels have been associated with impaired brain function. Many of our male study participants also had testosterone deficiency that required treatment.

Medication Review

Dr. Teitelbaum found that a number of study participants were on medications that may have contributed significantly to their confusion or illness. These were either modified, stopped or changed to more appropriate alternatives with the primary physician and family's consent. Note: some anti-depressants, antihistamines, and medications for incontinence and pain medications in particular worsen Alzheimer's Disease.

Findings

The duration of the study was initially planned to be six months. The study included a wide range of participants who had been diagnosed with various types of dementia, including Alzheimer's Disease. Study participants ranged in degree of cognitive impairment from mild cognitive impairment to mid-stage Alzheimer's Disease. Because of logistical difficulties families had in implementing the protocol, the treatment time was lengthened as needed to complete it.

Based on the study participants and their families self reports, the response to Dr. Teitelbaum's comprehensive approach varied based on several factors. Study participants in the early stages of their illness often responded well with noticeable improvements in cognitive and functional abilities within the six month time frame, as did those who had been diagnosed incorrectly and may not have actually had any form of dementia. We did not see the same degree of response from study participants with more severe illness. For these participants we continued to implement the study protocol for about one year. Though we did not see further decline in most cases, and a fair number of subjects felt subjectively that they were doing much better, we did not see a dramatic level of cognitive improvements in those with severe illness. So although the effectiveness was likely greater than that of available Alzheimer's medications, the approach certainly does not represent a cure. Generally, people found that their function subjectively improved or stabilized, with some people showing continuing decline as is normal with Alzheimer's

Challenges

Working remotely with no control over pre- and post-study cognitive assessments was a concern and potentially affected consistency. Working remotely also resulted in reliance on some insurance plans that did not allow our office to order necessary testing or prescribe for some study participants. This compromised some assessments/treatment plans when participants' local physicians were not open to the full protocol. In addition, treating at a distance made it difficult to manage certain issues that interfered with the study participants' compliance with their treatment plan.

Some caregivers (and participants) found the treatment protocol overwhelming. Adjustments were made to minimize or eliminate any stress associated with the protocol but this also compromised treatment at times. Stress in the home had a tremendous impact on the lack of success of the study participants' treatment protocol. As we know, caregiver stress is high, particularly for those who are still working at regular jobs while also trying to provide care.

Discussion

First and foremost, the lack of proper understanding, evaluation and treatment of cognitive impairments in the aging population by our medical community needs to be addressed. If you are not comfortable with the assessment or the outcome of your physician's assessment, look for another opinion. Confusion, memory problems, or any type of poor brain function IS NOT a part of normal aging and when identified, questions should be asked to address why this is happening.

As we already suspected, early intervention and even prevention in those with a family history is key, even with a complex, comprehensive approach as was utilized with the study. We don't know if mid-stage, more severe cases would benefit from use of the protocol longer than one year. But this is worth exploring since many people suffering with Alzheimer's Disease are already at this stage of their illness.

It is crucial to work with practitioners who are open to a thorough assessment with proper, extensive testing, and who are willing to consider treating the patient's history and symptoms. It was surprising to see how many study participants, and many others who our staff has worked with since the study, have not had even basic testing done in areas such as thyroid function, vitamin B12 levels and Homocysteine levels.

Prevention is key followed by giving a tuneup to optimize function! The recommendations listed below can be used as a strategy to help maintain and recover optimal brain function.

NOTE: Holistic physicians are more likely to be familiar with the concepts needed to optimize function. They can be found at the websites for the Academy of Integrative Health & Medicine and the American Association of Naturopathic Physicians.

Recommendations for Optimizing Cognitive Function

We would like to offer some general recommendations for folks who are seeking assistance for family members or for prevention for those who may be at risk of, and would like to avoid, cognitive dysfunction.

Initial considerations include a healthy diet, good quality sleep, and exercise especially for prevention. However, it is important to note that extreme diets and extreme exercise routines are not necessary. Dr. Teitelbaum is a firm believer in "all things in moderation." I know it can be difficult to push a healthy diet on family members who are confused so it is not a good idea to stress yourself or your loved one by making dramatic changes. Making small changes is the better way to introduce healthier food choices where possible.

For exercise, we simply recommend going for regular walks in the sunshine. The vitamin D from sunshine helps protect brain function.

The key is that there isn't a single magic bullet. When someone develops any form of dementia, this stems from years of things that have been going awry in the body that then finally manifest with symptoms. Treatment and prevention require a comprehensive approach. This may include the use of the prescription medications such as Aricept and Namenda. These can be helpful as long as they don't cause any side effects or worsen the cognitive problems. As mentioned above, this is just one tool in the treatment of the illness. Dr. Teitelbaum recommends starting with Aricept 5 mg before adding any Namenda. Namenda can be difficult to dose and at too high and too fast a dose it can cause problems with gait and increase the risk of falls. These medications should not be continued if, after starting, you notice an increase in confusion, memory loss or even delusions. Do not assume that the dementia is getting worse if symptoms worsen after beginning either of these medications. If they are not clearly helping within six weeks, and are causing significant side effects, you should consider discontinuing them.

We recommend starting with the following to help optimize cognitive function:

1. Nutritional Support (one drink with item 1 and 7 below, along with item 5 are key, and can be done very simply with as little as one drink and one pill daily)
   1. A good multivitamin. We use Dr. Teitelbaum's Energy Revitalization System vitamin powder, which supplies 50 key nutrients in one simple drink. For those who don't like powders, a multivitamin supplement called Clinical Essentials is also excellent .
   2. Vitamin B12. This is often deficient as we age and tends to be lower in folks with Alzheimer's Disease. Even normal blood levels may be inadequate. One 5,000 mcg sublingual or chewable tablet per day is recommended. After three months, the amount in supplement #1 above is adequate in the B12 may be discontinued
   3. Vitamin D. Low levels have also been linked to cognitive impairments as we age. Vitamin D levels should be tested but typically 2,000-5,000IU's per day is helpful, and can be started without blood testing. After six months, the amount in the supplement described in item 1 above is adequate.
   4. Coconut oil. Start with 1 tsp per day and work up to 4 tablespoons if possible. This is not effective for everyone. But for the 30%-plus folks that it does help, it is dramatic when the higher dosing is sustained. (A good book on this is Alzheimer's Disease: What If There Was a Cure?: The Story of Ketones.)
   5. Curcumin. Curcumin is a natural anti-inflammatory. Alzheimer's is 70% less common in India, and this has been attributed to the high curcumin diet from curries. The only brand that I would use is one called CuraMed, taking a 750 mg capsule once or twice daily (as many as 500 pills a day of other brands would be required to get a similar effect!).
   6. Probiotics. Proper digestion and brain health are proven to be linked. Taking one of the Probiotic Pearls Elite daily is a good choice.
   7. D-ribose. This is a nutrient that feeds every cell in the body. One 5 gram scoop each morning is recommended. This can simply be added to the vitamin powder described in item A1 above.
2. Sleep Support
   1.  Good sleep is key to improving brain function and we recommend starting with a low dose of Melatonin at bedtime, 0.5-1mg. This is often enough to help folks fall asleep and improve sleep quality. If there is frequent urinating at night a supplement called SagaPro® at bedtime can help minimize this. 
   2. Two herbal mixes can also be very helpful for sleep. These are the Revitalizing Sleep Formula and Terrific Zzzz™. These can be used together and in combination with melatonin.
3. Metabolism
   1. We recommend optimizing hormonal function based on both symptoms and lab tests. Be aware that even if your lab tests are normal, that does not mean that there is not a deficiency.
   2. Thyroid levels that are either too high or too low have been associated with dramatically increased risk of dementia. Fatigue, weight gain, and cold intolerance are suggestive of inadequate thyroid and we recommend considering a trial of Armour Thyroid to see if the person feels better.
   3. Irritability when hungry can suggest low adrenal. This can cause recurrent low blood sugar levels which can aggravate cognitive function and irritability. If a person feels irritabile when hungry, we recommend taking an adrenal supplement called Adrenaplex® each morning. If this is going to help, it should do so within a few weeks.
   4. If the testosterone level is under 400 in men, we usually recommend taking a supplement with bioidentical testosterone by prescription (start slowly at a dose of 25-50 mg of a topical cream).
4. Infections (even mild low-grade hidden infections can aggravate cognitive function)
   1. A gut infection should be suspected if there is increased gas/flatus. If nasal congestion and postnasal drip (clearing your throat a lot) is also present, we recommend taking a good probiotic (e.g., Probiotics Pearls Elite, once a day) and decreasing sugar intake. Adding the supplement Caprylex™ for 4-5 months is also helpful (resume taking it afterwards if symptoms recur).
   2. If the gas has a sulfur smell (think of the "silent but deadlies" back in grade school), this suggests a bacterial overgrowth in the small intestine. We recommend taking Ultra MFP Forte two twice a day for one bottle to see if it makes the smell go away. It can be taken intermittently as needed if the smell recurs
   3. Make sure any hidden bladder infections are treated. If the infection is from a bacteria called E. coli, use a supplement called D-Mannose to help keep the bladder clear.
5. Drugs. Ask your physician to eliminate any medications that are not essential to see if mental clarity improves. Be especially sure to leave off any antihistamines (e.g., Benadryl) or medications for urine incontinence. Both of these can especially play havoc with memory. A supplement called SagaPro® can be very helpful for urine incontinence.
6. We did not find that the Methylene Blue was as helpful as we had hoped, and because it's a powerful dye it was especially problematic for people with incontinence. It may be helpful for slowing progression, but we did not see a dramatic clinical improvement using it short term.

Another consideration is antioxidant support. We recommend Alpha Lipoic Acid 300 mg daily because it is a great antioxidant and easily crosses the blood brain barrie. You can also add N-Acetyl Cysteine 650 mg daily to help glutathione production. For high Homocysteine levels we recommend a supplement that includes a mix of ingredients designed for addressing high levels, such as Homocysteine Factors.

Original MIND Study Description

Below is the original description of the MIND Study.

Alzheimer's & Dementia: A Few Other Considerations

Dementia is a devastating condition affecting upwards of 10,000,000 Americans, with approximately 5 million having Alzheimer's Disease (AD). Dementia can be triggered by numerous causes, including Alzheimer's, multi-infarct dementia, and nutritional deficiencies. Treatment is currently geared towards giving 2 modestly helpful medications, Aricept and Namenda. Numerous studies show that many factors increase the risk of developing dementia, and there is no reason to believe those factors stop contributing to progression and impairment once the dementia occurs. Unfortunately, these factors are largely not addressed in treating these conditions.

Let's Begin with an Important Concept

In most organs, such as the kidney and lungs, over 50% of function can be lost without much clinical effect. As the damage increases, however, eventually small changes in function can have dramatic clinical implications. Likely, this also occurs in dementia, which is why some days the person may function quite well and other days they may not remember their children. It is suspected that fluctuations may occur for a number of reasons, as many factors affect brain function.

This leads to a common sense hypothesis: A simple yet comprehensive program aimed at optimizing brain function may increase the person's ability to function in dementia. This may be done by optimizing factors shown to impact the likelihood of developing dementia (e.g., thyroid and other hormone levels, nutritional factors, treating infections) as well as incorporating low-cost and benign treatments that have clinically been shown to be helpful, but do not get much attention because they are low cost.

M.I.N.D., a Simple Acronym to Focus Your Evaluation and Treatment

Metabolism:

Optimize thyroid and testosterone function.

In 2004, investigators at Wayne State University examined testosterone levels in men enrolled in a larger aging study. They found that every 50% increase in free testosterone in the bloodstream was associated with a 26% decrease in the risk of developing Alzheimer's. Men who went on to develop Alzheimer's disease had about half the free testosterone in their bloodstreams as men who did not. More is not better though. In one study where a much too high dose of 100 mg a day was given, underlying heart disease was unmasked, increasing heart attack risk early on. 25-50 mg a day topical is a reasonable dose in men if the testosterone level is under 450 ng/dl. CAUTION: Elevated testosterone in women can cause diabetes, so women should be careful not to come into contact with this. Thyroid is also critical. In the Framingham study, women in the lowest and highest third of serum TSH (thyroid test) concentrations had more than twice the risk of developing Alzheimer's.

Infections

Does your mind feel fuzzy when you have an infection? Ignoring "asymptomatic" bladder infections can be perilous! In addition, Candida is a common cause of post nasal drip and constant throat clearing as well as increased gas. The expression "old fart" may in part come from Candida! Sinusitis also needs to be treated.

Nutrition

The typical American diet is just as bad for your brain and memory as it is for your heart, leading to cell-damaging inflammation throughout the body, including the brain. Good brain function relies on the right nutritional support. We'll start by introducing a high-potency vitamin powder along with other key nutrients such as fish oil, curcumin, and Methylene Blue. Additionally, iron and B12 levels will be evaluated and treated if necessary. For study participants with a history of allergies, this may also be explored as part of the study.

Drugs

Eliminate any that are not clearly needed.