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large Alzheimer's clinical trial positive results

resveratrol alzheimers clinical trial

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#1 geo12the

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Posted 14 September 2015 - 04:44 PM


FYI:

 

http://www.scienceda...50911164211.htm

 

Neurology. 2015 Sep 11. pii: 10.1212/WNL.0000000000002035. [Epub ahead of print]
A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease.
Author information
  • 1From the Department of Neurology (R.S.T., B.A.R.), Georgetown University, Washington, DC; the Department of Neurosciences (R.G.T., J.B.B., R.A.R., R.R., P.S.A.), University of California, San Diego, La Jolla; the Department of Internal Medicine (S.C.), Wake Forest University, Winston-Salem, NC; the Departments of Psychiatry, Neurology, and Neurobiology (C.H.v.D.), Yale University, New Haven, CT; and the Clinical Biotechnology Research Institute (J.M.), Roper St. Francis Healthcare, Charleston, SC. rst36@georgetown.edu.
  • 2From the Department of Neurology (R.S.T., B.A.R.), Georgetown University, Washington, DC; the Department of Neurosciences (R.G.T., J.B.B., R.A.R., R.R., P.S.A.), University of California, San Diego, La Jolla; the Department of Internal Medicine (S.C.), Wake Forest University, Winston-Salem, NC; the Departments of Psychiatry, Neurology, and Neurobiology (C.H.v.D.), Yale University, New Haven, CT; and the Clinical Biotechnology Research Institute (J.M.), Roper St. Francis Healthcare, Charleston, SC.
Abstract
OBJECTIVE:

A randomized, placebo-controlled, double-blind, multicenter 52-week phase 2 trial of resveratrol in individuals with mild to moderate Alzheimer disease (AD) examined its safety and tolerability and effects on biomarker (plasma Aβ40 and Aβ42, CSF Aβ40, Aβ42, tau, and phospho-tau 181) and volumetric MRI outcomes (primary outcomes) and clinical outcomes (secondary outcomes).

METHODS:

Participants (n = 119) were randomized to placebo or resveratrol 500 mg orally once daily (with dose escalation by 500-mg increments every 13 weeks, ending with 1,000 mg twice daily). Brain MRI and CSF collection were performed at baseline and after completion of treatment. Detailed pharmacokinetics were performed on a subset (n = 15) at baseline and weeks 13, 26, 39, and 52.

RESULTS:

Resveratrol and its major metabolites were measurable in plasma and CSF. The most common adverse events were nausea, diarrhea, and weight loss. CSF Aβ40 and plasma Aβ40 levels declined more in the placebo group than the resveratrol-treated group, resulting in a significant difference at week 52. Brain volume loss was increased by resveratrol treatment compared to placebo.

CONCLUSIONS:

Resveratrol was safe and well-tolerated. Resveratrol and its major metabolites penetrated the blood-brain barrier to have CNS effects. Further studies are required to interpret the biomarker changes associated with resveratrol treatment.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that for patients with AD resveratrol is safe, well-tolerated, and alters some AD biomarker trajectories. The study is rated Class II because more than 2 primary outcomes were designated.

 



#2 geo12the

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Posted 14 September 2015 - 06:15 PM

upon reading the article its not a large trial but a small one. Results still promising. 



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#3 ceridwen

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Posted 14 September 2015 - 06:50 PM

Not keen on the brain volume loss. I wonder what would happen if combined with B Vitamins. I am also not keen on the fact that there was no cognitive improvement because really nothing else matters. It gives me diaherrea in large amounts. I don't think I'll bother.
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#4 geo12the

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Posted 14 September 2015 - 11:06 PM

Not keen on the brain volume loss. I wonder what would happen if combined with B Vitamins. I am also not keen on the fact that there was no cognitive improvement because really nothing else matters. It gives me diaherrea in large amounts. I don't think I'll bother.

 

They discuss the brain volume thing:

 

"The etiology and interpretation of brain volume loss

observed here and in other studies are unclear, but
they are not associated with cognitive or functional
decline. In the first human active Ab immunization
trial, antibody responders had greater brain volume
loss, and greater volumetric changes were associated
with higher antibody titers."
 
Just pure speculation on my part but I wonder if  the reduced volume = reduced inflammation. If so that would be good. 
 
The treatment was 2 years on resveratrol. If you look at the cognitive scores they were better in a few of the different measures in the Resveratrol group, but did not reach the level of statistical significance. Could be a larger sample size and/or longer treatment would show statistical significance.

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#5 Bryan_S

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Posted 21 September 2015 - 12:28 AM

Good discussion guys.

 

We touched on this study the other week because it is a sirtuin activator related to Pterostilbene. See posts while this is encouraging Resveratrol support is waning in favor of the more potent pterostilbeneSee full-text link "Low-dose pterostilbene, but not resveratrol, is a potent neuromodulator in aging and Alzheimer’s disease credit to APBT for finding this text. So you be the Judge but I think if this comparative study had been published before the Georgetown study commenced in 2012 they would have looked at Pterostilbene over Resveratrol since it is more bioactive.

 

So any headway they make on this topic is exciting for all of us but one factor David Sinclair and Leonard Guarantee both discovered is that these related sirtuin activators are NAD+ consumers. Thru their research it was discovered they alone did little to alter the metabolism if the NAD pool was already limited or diminished. So if you take either of these molecules as SIRT1 activators you should also boost your NAD+ levels to accommodate the metabolic needs of these molecules. In fact just raising NAD+ levels will increase SIRT1 anyway without Resveratrol or Pterostilbene but I'm sure they intended other targets as well. http://www.the-scien...he-Aging-Brain/

 

Here is the PDF of A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease Now if they had supplemented the test subjects with a NAD precursor the results could have been more dramatic but they certainly made their point. 

 

This caught my eye in the Full PDF version in the Discussion section "Weight and fat loss with resveratrol are reported in some preclinical studies,4 but human studies are scarce and of shorter duration. A decrease in body fat and a trend toward weight loss were reported in a 26- week trial with 200 mg/day resveratrol in healthy older participants.33 Weight and fat loss may be related to enhanced mitochondrial biogenesis mediated by SIRT1 activation of PCG-1a.4,10,11" So they may have been able to raise NAD levels to accomplish this but it wasn't apparent to me after reading the study that this group lost weight. "200 mg/day resveratrol in healthy older participants" From the study "Participants (n 5 119) were randomized to placebo or resveratrol 500 mg orally once daily (with dose escalation by 500-mg increments every 13 weeks, ending with 1,000 mg twice daily)" so there is my confusion over weight loss in this study I think they were talking about another study.

 

Related study:

Nicotinamide Phosphoribosyltransferase May Be Involved in Age-Related Brain Diseases

http://journals.plos...al.pone.0044933


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#6 mrwhitee

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Posted 25 September 2015 - 01:05 AM

I wonder what brand of resveratrol they used? I wonder if the cheap stuff from revgenetics (X500) would work or if need to be Longevinex? 2 grams of Longevinex would be expensive.



#7 ceridwen

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Posted 25 September 2015 - 01:12 AM

but according to yesterday's Science Daily a new Alzheimer's Drug has been found Salsalate to completely reverse Alzheimer's in mice. It is available now as it is an rheumatic drug. That sounds much more exciting to me
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#8 bluemoon

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Posted 25 September 2015 - 10:33 PM

I wonder what brand of resveratrol they used? I wonder if the cheap stuff from revgenetics (X500) would work or if need to be Longevinex? 2 grams of Longevinex would be expensive.

 

It seems that trials use Biotivia, probably since inexpensive, about the same as Revgenetics. I reallyy doubt Longevinex was used because of the price. If it was used, we'll hear about it through that company..



#9 niner

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Posted 26 September 2015 - 03:05 AM

 

I wonder what brand of resveratrol they used? I wonder if the cheap stuff from revgenetics (X500) would work or if need to be Longevinex? 2 grams of Longevinex would be expensive.

 

It seems that trials use Biotivia, probably since inexpensive, about the same as Revgenetics. I reallyy doubt Longevinex was used because of the price. If it was used, we'll hear about it through that company..

 

Is there some trial documentation that says they used Biotivia?  The Biotivia guys are infamous for claiming that various trials used their branded products when that was not actually the case.  I haven't looked at their products in quite a while, but I seem to recall them being 50% extracts.  Maybe that's changed, I don't know.  I think it's unlikely that they would use Longevinex, since it contains a bunch of other stuff besides resveratrol.  I would expect them to use a high purity (99+%) resveratrol in the trial.  



#10 mrwhitee

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Posted 26 September 2015 - 03:22 AM

I dont know if its correct but in an email from swansons vitamins it said they used a synthetic molecular copy.

 

 



#11 niner

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Posted 26 September 2015 - 04:08 AM

OK, I found the paper and looked at the Materials & Methods section.  It states:
 

Study medication.
Aptuit Laurus, Inc. (Kansas City, MO, now Catalent, Inc., Somerset, NJ) synthesized and encapsulated resveratrol (trans-3,5,4'-trihydroxystilbene) and provided identical placebo, according to current Good Manufacturing Practices.  The dose escalation was in 500-mg increments every 13 weeks
as follows: 500 mg QAM, 500 mg BID, 1,000 mg QAM and 500 mg QPM, and 1,000 mg BID.

 

So there you have it.  No supplement company was involved.  You could get an essentially identical product by buying a high-purity resveratrol from one of the vendors like Revgenetics or others.


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#12 ceridwen

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Posted 26 September 2015 - 06:22 PM

however you look at it it did not reverse the symptoms to the patients and families that's all that matters.
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#13 mrwhitee

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Posted 26 September 2015 - 06:25 PM

OK, I found the paper and looked at the Materials & Methods section.  It states:
 

Study medication.
Aptuit Laurus, Inc. (Kansas City, MO, now Catalent, Inc., Somerset, NJ) synthesized and encapsulated resveratrol (trans-3,5,4'-trihydroxystilbene) and provided identical placebo, according to current Good Manufacturing Practices.  The dose escalation was in 500-mg increments every 13 weeks
as follows: 500 mg QAM, 500 mg BID, 1,000 mg QAM and 500 mg QPM, and 1,000 mg BID.

 

So there you have it.  No supplement company was involved.  You could get an essentially identical product by buying a high-purity resveratrol from one of the vendors like Revgenetics or others.

 

 

Thanks niner!



#14 mrwhitee

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Posted 26 September 2015 - 06:36 PM

however you look at it it did not reverse the symptoms to the patients and families that's all that matters.

 

Maybe it can help prevent the disease in those at high risk and maybe other things too.


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#15 ceridwen

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Posted 26 September 2015 - 06:41 PM

Well that would be good but I don't think it would halt it would it?
Well that would be good but I don't think it would halt it would it?

#16 mrwhitee

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Posted 26 September 2015 - 09:06 PM

Well that would be good but I don't think it would halt it would it?
Well that would be good but I don't think it would halt it would it?

 

 

 

I dont know but it would be nice if it just slowed it down till something better comes along. I guess we wont know till they do larger studies.

 

If its true that hsv-1 causes AD or at least some of it then mega doses of resveratrol might prevent it for those people.



#17 bixbyte

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Posted 29 September 2015 - 02:23 PM

Guess what RES is more than a Beta Amyloid "buster" for AD.

I have been supplementing with Resveratrol for numerous years.

You know what I have discovered?

Supplementing with large does of Resveratrol makes me think I am smarter and my memory works better.

Obviously, I do not have any concrete evidence.

Someone would need to perform a double blind multiyear PII trial dosing on RES and have the two dosing groups memory tested.

Anyone else have benefits supplementing with large doses of RES over many Years?

 

 



#18 ceridwen

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Posted 29 September 2015 - 10:30 PM

No but I was only taking it for a few months not many years. It gave me diarrhoea. There may be more than 1 sort of Alzheimer's

#19 mrwhitee

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Posted 30 September 2015 - 02:15 AM

While searching for high dose resveratrol I see a lot of info about it being more harmful than good. Maybe its not good to megadose if you dont have a good reason to.



#20 bixbyte

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Posted 30 September 2015 - 05:19 AM

No but I was only taking it for a few months not many years. It gave me diarrhoea. There may be more than 1 sort of Alzheimer's

 

If you had the Runs there is a high possibility that your Resveratrol contains large amounts of Emodin.

Buy the good stuff tested 98% or 99% pure white Res.



#21 ceridwen

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Posted 30 September 2015 - 04:01 PM

Yes it did but I'm not at all confident that removing what people think might be the markers of a disease without removing the symptoms is any use at all. Some scientists are now beginning to think that there is a sweet spot for amyloid where it actually increases neurogenesis and that without amyloid memory problems increase so it's possible that the research is going in the wrong direction. All I can say is I did not notice any cognitive changes while taking it at any time and I took high doses both with and without Emodin. It doesn't relieve memory loss

#22 ceridwen

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Posted 30 September 2015 - 04:04 PM

Well not for me anyway. See the latest broadcast by Super Human Radio for more details about the amyloid results I am referring to.

#23 bixbyte

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Posted 02 October 2015 - 02:15 PM

Yes it did but I'm not at all confident that removing what people think might be the markers of a disease without removing the symptoms is any use at all. Some scientists are now beginning to think that there is a sweet spot for amyloid where it actually increases neurogenesis and that without amyloid memory problems increase so it's possible that the research is going in the wrong direction. All I can say is I did not notice any cognitive changes while taking it at any time and I took high doses both with and without Emodin. It doesn't relieve memory loss

Scientists at the Stanford University School of Medicine have shown how a protein fragment known as beta-amyloid, strongly implicated in Alzheimer’s disease, begins destroying synapses before it clumps into plaques that lead to nerve cell death.

Key features of Alzheimer’s, which affects about 5 million Americans, are wholesale loss of synapses — contact points via which nerve cells relay signals to one another — and a parallel deterioration in brain function, notably in the ability to remember.

“Our discovery suggests that Alzheimer’s disease starts to manifest long before plaque formation becomes evident,” said Carla Shatz, PhD, professor of neurobiology and of biology and senior author of the study, published Sept. 20 in Science.
 
Investigators at Harvard University also contributed to the study. The research, conducted in mice and in human brain tissue, may help to explain the failures in recent years of large-scale clinical trials attempting to slow the progression of Alzheimer’s by pharmacologically ridding the brain of amyloid plaques. It may also point the way to better treatments at earlier stages of the disease.

Beta-amyloid begins life as a solitary molecule but tends to bunch up — initially into small clusters that are still soluble and can travel freely in the brain, and finally into the plaques that are hallmarks of Alzheimer’s. The study showed for the first time that in this clustered form, beta-amyloid can bind strongly to a receptor on nerve cells, setting in motion an intercellular process that erodes their synapses with other nerve cells.

Synapses are the connections between nerve cells. They are essential to storing memories, processing thoughts and emotions, and planning and ordering how we move our bodies. The relative strength of these connections, moreover, can change in response to new experiences.

Using an experimental mouse strain that is highly susceptible to the synaptic and cognitive impairments of Alzheimer’s disease, Shatz and her colleagues showed that if these mice lacked a surface protein ordinarily situated very close to synapses, they were resistant to the memory breakdown and synapse loss associated with the disorder. The study demonstrated for the first time that this protein, called PirB, is a high-affinity receptor for beta-amyloid in its “soluble cluster” form, meaning that soluble beta-amyloid clusters stick to PirB quite powerfully. That trips off a cascade of biochemical activities culminating in the destruction of synapses.

 

Bixbyte: The Scientists in this study say Beta-Amyloids cause Brain Damage.


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#24 Phlogiston

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Posted 20 October 2015 - 03:12 AM

Can someone educate me on the significance of the fact that AB40 levels declined more in the placebo group than in the resveratrol group?  Wouldn't a decrease in AB40 be desirable?



#25 Phlogiston

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Posted 21 October 2015 - 03:28 AM

And is there a consensus here as to what it means that brain volumes declined in the resveratrol group?  To me, this sounds ominous rather than encouraging.

 

I would like to hear from somebody with clinical training as to why the researchers sound so noncommittal about this result. I have always seen decline in brain volume discussed as if it were a prima facie indication of neurodegeneration, but I am a lay person so this view could be oversimplified.



#26 ceridwen

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Posted 21 October 2015 - 12:40 PM

They tried to pass if off as an improvement as if the brains were swollen at first sinking back to their right size on Resveratrol. When I 1st read the article I thought they were saying that Resveratrol does not work for Alzheimer's because there were no noticeable improvements in memory but they were saying that it was good by looking at biomarkers. There is only 1 thing that matters to patients and their familys were there any health improvements or not? I heard a radio program saying that it halted the disease but I don't think the paper said that. Did it? Really upset.
I am taking Pterostilbene because I heard it can stop decline. Is that true? Or is its mechanism too much like Resveratrol's?
Would natural Resveratrol be better than the supplements. Or can eating grapes shrink the brain as well?

#27 Phlogiston

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Posted 21 October 2015 - 02:49 PM

I don't know Ceridwen. Bear in mind that this study used 2000 mg a day, at least 10 times the dose that most supps contain. But like you I don't understand what is so positive about these results. If AB40 is an amyloid marker, it seems to me that a decline in levels would be the desired result. But AB40 levels actually declined more in the control group than the resveratrol group. That is why I wish someone with more academic background in this area would tell us why this is considered a successful study.

 

Ceridwen, have you ever seen the MEND protocol for reversing age related memory loss? It was developed at the UCLA center for memory disorders and has had dramatic results for people such as you and I.  I cannot link to it but will try to attach it to this post. I tend to proselytize for it around here, because it is the most promising thing available for people in your situation or mine.

 

 

Attached Files



#28 ceridwen

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Posted 21 October 2015 - 03:32 PM

Thanks Are you on this? The people who gave up carbs completely did best. I'm full of admiration if you are. It could be caused by a fungus so giving up carbs removes an important food source for the fungus and the other stuff boosts immunity. I am going to look at anti fungals though and attempt to get rid of it that way. I shall probably have to go on this eventually but looking to see if there is anything else I could do that might work first

#29 sthira

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Posted 21 October 2015 - 05:33 PM

It could be caused by a fungus so giving up carbs removes an important food source for the fungus and the other stuff boosts immunity. I am going to look at anti fungals though and attempt to get rid of it that way. I shall probably have to go on this eventually but looking to see if there is anything else I could do that might work first


Ceridwen, since you're looking for causes, have you looked into a 23&me test? It's not much money and may give you additional insight?

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#30 geo12the

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Posted 21 October 2015 - 05:52 PM

And is there a consensus here as to what it means that brain volumes declined in the resveratrol group?  To me, this sounds ominous rather than encouraging.

 

I would like to hear from somebody with clinical training as to why the researchers sound so noncommittal about this result. I have always seen decline in brain volume discussed as if it were a prima facie indication of neurodegeneration, but I am a lay person so this view could be oversimplified.

 

I don't have clinical training but my understanding is that neurodegeneraton is accompanied by brain inflammation:

 

Immunology. 2010 Feb; 129(2): 154–169.

Inflammation in neurodegenerative diseases

Sandra Amor,1,2 Fabiola Puentes,2 David Baker,2 and Paul van der Valk1

Author information ► Article notes ► Copyright and License information ►

This article has been cited by other articles in PMC.

Go to:

ABSTRACT

Neurodegeneration, the slow and progressive dysfunction and loss of neurons and axons in the central nervous system, is the primary pathological feature of acute and chronic neurodegenerative conditions such as Alzheimer’s disease and Parkinson’s disease, neurotropic viral infections, stroke, paraneoplastic disorders, traumatic brain injury and multiple sclerosis. Despite different triggering events, a common feature is chronic immune activation, in particular of microglia, the resident macrophages of the central nervous system. Apart from the pathogenic role of immune responses, emerging evidence indicates that immune responses are also critical for neuroregeneration. Here, we review the impact of innate and adaptive immune responses on the central nervous system in autoimmune, viral and other neurodegenerative disorders, and discuss their contribution to either damage or repair. We also discuss potential therapies aimed at the immune responses within the central nervous system. A better understanding of the interaction between the immune and nervous systems will be crucial to either target pathogenic responses, or augment the beneficial effects of immune responses as a strategy to intervene in chronic neurodegenerative diseases.

Neurodegeneration, the slow and progressive dysfunction and loss of neurons and axons in the central nervous system, is the primary pathological feature of acute and chronic neurodegenerative conditions such as Alzheimer’s disease and Parkinson’s disease, neurotropic viral infections, stroke, paraneoplastic disorders, traumatic brain injury and multiple sclerosis. Despite different triggering events, a common feature is chronic immune activation, in particular of microglia, the resident macrophages of the central nervous system. Apart from the pathogenic role of immune responses, emerging evidence indicates that immune responses are also critical for neuroregeneration. Here, we review the impact of innate and adaptive immune responses on the central nervous system in autoimmune, viral and other neurodegenerative disorders, and discuss their contribution to either damage or repair. We also discuss potential therapies aimed at the immune responses within the central nervous system. A better understanding of the interaction between the immune and nervous systems will be crucial to either target pathogenic responses, or augment the beneficial effects of immune responses as a strategy to intervene in chronic neurodegenerative diseases.

 

In this paper they mention that brain inflammation may potentially cause increases in brain volume size:

 

Arch Neurol. 2012 Jan;69(1):82-8. doi: 10.1001/archneurol.2011.674.

Impact of inflammation on brain volume in multiple sclerosis.

Abstract

OBJECTIVE:

To study changes in brain volume measured monthly in patients treated for relapsing multiple sclerosis due to loss of tissue and the appearance of inflammation.

DESIGN AND PATIENTS:

The results from T2/fluid-attenuated inversion recovery axial images from 13 consecutive monthly 3-T brain magnetic resonance imaging tests conducted on 74 patients diagnosed with relapsing multiple sclerosis in the BECOME study were used to calculate whole brain volumes using automated software analysis tools. The patients had been randomized to receive treatment with interferon beta-1b or glatiramer acetate. Ongoing inflammation was studied by counting the number of combined active lesions and measuring the volume of gadolinium enhancement. A mixed-effects model was used to analyze brain volumes over time.

RESULTS:

There was a significant decrease in brain volume over time but there was no difference in its rate of change by age, sex, frequency of ongoing inflammation, multiple sclerosis type, or randomized treatment assignment. The mean rate of brain volume change per month from multivariable models was -1.1 cm(3) (95% CI, -1.5 to -0.6) and during times of magnetic resonance imaging activity, it increased transiently by an average of 1.2 cm(3)/lesion (95% CI, 0.7 to 1.7) and 7.1 cm(3)/1 cm(3 )of gadolinium volume. In a model with both measures, combined active lesions were independent predictors of brain volume but gadolinium volume was not.

CONCLUSION:

Two major changes in brain volume occur in patients with relapsing multiple sclerosis, a steady decrease likely due to tissue loss with overlapping transient increases due to the appearance of inflammation.

 

Note that the study in the original post was performed on people with Alzheimer's. Its likely they have some level of brain inflammation. If Resveratrol relieves brain inflammation it actually makes sense that you would see a small decrease in brain volume.


Edited by geo12the, 21 October 2015 - 05:56 PM.






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