Cognition improved with neutraceuticals

[Julie G]

This is encouraging. A small placebo controlled trial demonstrates that a nutraceutical formulation (folate, alpha-tocopherol, B-12, S-adenosyl methioinine, N-acetyl cysteine, and acetyl-L-carnitine) improves cognition in those DXed with MCI.

http://www.j-alz.com/content/fsu-profes ... rment-when

Here's the paper:
A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension
http://www.ncbi.nlm.nih.gov/pubmed/26402075

If anybody can get full-text, I'd like to know more about the breadth and significance of the improvement.

[circular]

See also:

"A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease."

Abstract
BACKGROUND:
Increasing evidence points toward the efficacy of nutritional modifications in delaying cognitive decline and mood/behavioral difficulties in Alzheimer's disease (AD). Nutritional supplementation with individual agents has shown varied results suggesting the need for combinatorial intervention.

OBJECTIVE:
We set out to determine whether nutritional intervention could positively impact cognitive performance and behavioral difficulties for individuals diagnosed with AD.

METHODS:
A double-blind, multi-site, phase II study (ClinicalTrials.gov NCT01320527; Alzheimer's Association Trialmatch) was conducted in which 106 individuals with AD were randomized to a nutraceutical formulation (NF; folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or placebo for 3 or 6 months, followed by an open-label extension where participants received NF for 6 additional months.

RESULTS:
The NF cohort improved versus the placebo cohort within 3 months (Clox-1 p = 0.0083, 95%CI [0.4481, 2.9343]; Dementia Rating Scale p = 0.0266, 95%CI [0.1722, 2.7171]). Caregivers reported non-significant improvements in Neuropsychiatric Inventory. Both cohorts improved or maintained baseline performance during open-label extensions. Activities of Daily Living did not change for either cohort.

CONCLUSIONS:
These findings extend phase I studies where NF maintained or improved cognitive performance and mood/behavior.

[Gilgamesh]

If anybody can get full-text, I'd like to know more about the breadth and significance of the improvement.

Me too! -- and esp. about whether APOE status was controlled for.

[Stavia]

I'll look at work today if I can get it

[Lucy5]

Also whether the MTHFR gene was controlled for. I'd also like to know what folate formulation was used. My thinking here being that if the study included those with the MTHFR mutation (esp 2 copies), then adding the methylated forms of folate & B12 might contribute to the improvements seen? Just a thought from a layperson..

[Stavia]

Sorry guys, not on my database.
Richard???

[RichardS]

Sorry, can't get a free copy.

Here is the original abstract from the paper:

Thirty-four individuals with mild cognitive impairment were randomized for 6 months to a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or indistinguishable placebo, followed by a 6-month open-label extension in which all individuals received NF. The NF cohort improved in the Dementia Rating Scale (DRS; effect size >0.7) and maintained baseline performance in CLOX-1. The placebo cohort did not improve in DRS and declined in CLOX-1, but during the open-label extension improved in DRS and ceased declining in CLOX-1.These findings extend prior studies of NF efficacy for individuals without cognitive impairment and with Alzheimer'sdisease.

I wish I could see the rest of the stats, but the big picture here is that the original nutraceutical group not only did not decline over 6 months but showed an improvement greater than an effect size (ES) of 0.7. The convention is to consider an ES = 0.2 to be small, 0.5 medium and 0.8+ large. Unless there is a duplicate name (which is entirely possible), I know the (Mattis) Dementia Rating Scale having used it in the clinic as a post-doc because it is a good measure to track dementia over time, but I don't recognize CLOX-1. From the abstract that Circ posted, it looks like an average 1.5 points improvement on the scale. That is not anything dramatic, but if the effect persists, it would be worthwhile as part of a comprehensive treatment model. From the wide confidence intervals on the test results, I wonder if it is helping a select few a lot who at baseline really were low in these nutrients while leaving most people unaffected. Maybe the detailed stats would show if that is the case.

[kayell]

I believe this is the product used in the trial: http://www.thinkperceptiv.com/ It contains the same mix of supplements and on their page of clinical studies http://www.thinkperceptiv.com/clinical- ... perceptiv/ Ruth Remington is listed as first researcher on most of the papers. Remington, R is the lead researcher on the paper in question.

[SusanJ]

If this is the formula they tried, it would be interesting to see if they looked at all about outcomes and genetic variants. The formula uses plain folic acid which might not be helpful to MTHFR 677 homozygotes...

[Lucy5]

@Susanj, That's what I noticed too. What interests me, is if those w/a MTHFR mutation DID improve using the nonmethylated forms of folate & B12, then it would mean one or more of the other ingredients (i.e. ALCAR) were the reason. Like many others here, I take a number of supplements and am trying to tweak my protocol based on what current studies show to be impactful.

Thank you & everyone for all your analysis!! I am a real novice & can't tell you how thrilled I am to have access to your knowledge.