X-Message-Number: 32229
Date: Thu, 17 Dec 2009 21:21:21 -0800 (PST)
From:
Subject: evidence based OTC treatment of Alzheimer's disease IV
[A combination of pyridoxine (B6) 5 mg, folic acid 1 mg, and other vitamins and
iron s a dud.]
Clin Ther. 2007 Oct;29(10):2204-14.
Efficacy of multivitamin supplementation containing vitamins B6 and B12 and
folic acid as adjunctive treatment with a cholinesterase inhibitor in
Alzheimer's disease: a 26-week, randomized, double-blind, placebo-controlled
study in Taiwanese patients.
Sun Y, Lu CJ, Chien KL, Chen ST, Chen RC. Department of Neurology, En Chu Kong
Hospital, San-shia, Taipei, Taiwan.
BACKGROUND: Elevated serum homocysteine levels have been associated with the
development of Alzheimer's dementia (AD). The combined use of a mecobalamin
capsule preparation, which contains vitamin B12 0.5 mg with an active
methyl base, and an over-the-counter nutritional supplement that contains
folic acid 1 mg and pyridoxine hyperchloride 5 mg may be effective as a
homocysteine-lowering vitamin regimen. OBJECTIVE: The aim of this study was
to determine whether oral multivitamin supplementation containing vitamins
B6 and B12 and folic acid would improve cognitive function and reduce serum
homocysteine levels in patients with mild to moderate AD. METHODS: This
randomized, double-blind, placebocontrolled trial was conducted at En Chu
Kong Hospital, Taipei, Taiwan. Male and female patients aged >50 years with
mild to moderate AD and normal folic acid and vitamin B12 concentrations
were enrolled. All patients received treatment with an acetylcholinesterase
inhibitor and were randomized to receive add-on mecobalamin (B12) 500 mg +
multivitamin supplement, or placebos, PO QD for 26 weeks. The multivitamin
contained pyridoxine (B6) 5 mg, folic acid 1 mg, and other vitamins and
iron. Serum homocysteine level was measured and cognitive tests were
conducted at baseline and after 26 weeks. The primary efficacy outcome was
change in cognition, measured as the change in score from baseline to week
26 on the Alzheimer's Disease Assessment Scale 11-item Cognition subscale.
Secondary efficacy outcomes included changes in function in performance of
activities of daily living (ADLs) and concentrations of homocysteine, B12,
and folic acid. Tolerability was assessed by comparing the 2 study groups
with respect to physical examination findings, including changes in vital
signs, laboratory test abnormalities, concomitant medication use, and
compliance of study medication was assessed using an interview with the
patient's caregiver, as well as the monitoring of adverse events (AEs)
throughout the study. RESULTS: Eighty-nine patients (45 men, 44 women; all
Taiwanese; mean [SD] age, 75 [7.3] years) were enrolled and randomized.
Overall, there were no significant differences in cognition or ADL function
scores between the 2 groups. At week 26, the mean (SD) between-group
difference in serum homocysteine concentration versus placebo was -2.25
(2.85) micromol/L (P = 0.008), and the mean serum concentrations of vitamin
B12 and folic acid were significantly higher (but within normal range) in
the multivitamin group compared with placebo (., +536.9 [694.4] pg/mL [P <
0.001] and +13.84 ng/mL [11.17] [P = 0.012] at 26 weeks, respectively). The
2 most common AEs were muscle pain (11.1% and 6.8%) and insomnia (8.9% and
9.1%) in the multivitamin and placebo groups, respectively. CONCLUSIONS: In
this population of patients with mild to moderate AD in Taiwan, a
multivitamin supplement containing vitamins B(6) and B(12) and folic acid
for 26 weeks decreased homocysteine concentrations. No statistically
significant beneficial effects on cognition or ADL function were found
between multivitamin and placebo at 26 weeks.
PMID: 18042476
[Lipoic acid may be slightly beneficial.]
J Neural Transm Suppl. 2007;(72):189-93.
Alpha-lipoic acid as a new treatment option for Alzheimer's disease--a 48 months
follow-up analysis.
Hager K, Kenklies M, McAfoose J, Engel J, Munch G. Department of Medical
Rehabilitation and Geriatrics, Henriettenstiftung, Hannover, Germany.
Oxidative stress and neuronal energy depletion are characteristic
biochemical hallmarks of Alzheimer's disease (AD). It is therefore
conceivable that pro-energetic and antioxidant drugs such as alpha-lipoic
acid might delay the onset or slow down the progression of the disease. In a
previous study, 600mg alpha-lipoic acid was given daily to nine patients
with AD (receiving a standard treatment with choline-esterase inhibitors) in
an open-label study over an observation period of 12 months. The treatment
led to a stabilization of cognitive functions in the study group,
demonstrated by constant scores in two neuropsychological tests (the mini
mental state exam, MMSE and the Alzheimer's disease assessment score
cognitive subscale, ADAScog). In this report, we have extended the analysis
to 43 patients over an observation period of up to 48 months. In patients
with mild dementia (ADAScog < 15), the disease progressed extremely slowly
(ADAScog: +1.2 points/year, MMSE: -0.6 points/year), in patients with
moderate dementia at approximately twice the rate. However, the progression
appears dramatically lower than data reported for untreated patients or
patients on choline-esterase inhibitors in the second year of long-term
studies. Despite the fact that this study was not double-blinded,
placebo-controlled and randomized, our data suggest that treatment with
alpha-lipoic acid might be a successful 'neuroprotective' therapy option for
AD. However, a state-of-the-art phase II trial is needed urgently.
PMID: 17982894
[Conflicting results with NADH. Only stabilizated NADH was effective.]
Drugs Exp Clin Res. 2004;30(1):27-33.
Treatment of Alzheimer's disease with stabilized oral nicotinamide adenine
dinucleotide: a randomized, double-blind study.
Demarin V, Podobnik SS, Storga-Tomic D, Kay G. Department of Neurology, Sestre
Milosrdnice University Hospital, Zagreb, Croatia.
This study was designed to evaluate the effect of stabilized oral reduced
nicotinamide adenine dinucleotide (NADH) on cognitive functioning in
patients with Alzheimer's disease (AD). NADH is a coenzyme that plays a key
role in cellular energy production and stimulates dopamine production. In
previous trials NADH has been shown to improve cognitive functioning in
patients with Parkinson's disease, depression and AD. The present trial was
a randomized, placebo-controlled, matched-pairs, double-blind, 6-month
clinical study. Patients with probable AD (n = 26) were randomized to
receive either stabilized oral NADH (10 mg/day) or placebo. Twelve pairs of
subjects were matched for age and baseline total score on the Mattis
Dementia Rating Scale (MDRS) and the Mini Mental State Examination. After 6
months of treatment, subjects treated with NADH showed no evidence of
progressive cognitive deterioration and had significantly higher total
scores on the MDRS compared with subjects treated with placebo (p < 0.05).
Analysis of MDRS subscales revealed significantly better performance by NADH
subjects on measures of verbal fluency (p = 0.019), visual-constructional
ability (p = 0.038) and a trend (p = 0.08) to better performance on a
measure of abstract verbal reasoning. There were no differences between
groups in measures of attention, memory, or in clinician ratings of dementia
severity (Clinical Dementia Rating). Consistent with earlier studies, the
present findings support NADH as a treatment for AD.
PMID: 15134388
J Neural Transm. 2000;107(12):1475-81.
No evidence for cognitive improvement from oral nicotinamide adenine
dinucleotide (NADH) in dementia.
Rainer M, Kraxberger E, Haushofer M, Mucke HA, Jellinger KA. Memory-Clinic and
Psychiatric Department, Donauspital, Sozialmedizinisches Zentrum Ost, Wein,
Austria.
Reduced nicotinamide adenine dinucleotide (NADH) is advertised as an
over-the-counter product or dietary supplement to treat Alzheimer's disease.
We performed a 3-month open-label study with oral 10 mg/day NADH with 25
patients with mild to moderate dementia of the Alzheimer, vascular, and
fronto-temporal types in addition to their current cholinomimetic drug
medication. In 19 patients who completed the study, we found no evidence for
any cognitive effect as defined by established psychometric tests. We
conclude that NADH is unlikely to achieve cognitive improvements in an
extent reported earlier, and present theoretical arguments against an
effectiveness of this compound in dementia disorders.
PMID: 11459000
[An extract of lemon balm (melissa officinalis) extract was highly beneficial in
a small trial in Iran. While the placebo patients continued to deteriorate, the
lemon balm patients continuously improved throughout the trial. The results of
this trial have been largely ignored in the USA, which may be significant error
since the results exceed those of prescription drugs, which typically only slow
the decline, or help to temporarity stabilize patients.]
J Neurol Neurosurg Psychiatry. 2003 Jul;74(7):863-6.
Melissa officinalis extract in the treatment of patients with mild to moderate
Alzheimer's disease: a double blind, randomised, placebo controlled trial.
Akhondzadeh S, Noroozian M, Mohammadi M, Ohadinia S, Jamshidi AH, Khani M.
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran,
Iran.
OBJECTIVE: To assess the efficacy and safety of Melissa officinalis extract
using a fixed dose (60 drops/day) in patients with mild to moderate
Alzheimer's disease. DESIGN: A four month, parallel group, placebo
controlled trial undertaken in three centres in Tehran, Iran. METHODS:
Patients with mild to moderate Alzheimer's disease aged between 65 and 80
years (n = 42; 18 women, 24 men) with a score of >or= 12 on the cognitive
subscale of Alzheimer's disease assessment scale (ADAS-cog) and <or= 2 on
the clinical dementia rating (CDR) were randomised to placebo or fixed dose
of Melissa officinalis extract. The main efficacy measures were the change
in the ADAS-cog and CDR-SB scores compared with baseline. Side effects were
systematically recorded. RESULTS: At four months, Melissa officinalis
extract produced a significantly better outcome on cognitive function than
placebo (ADAS-cog: df = 1, F = 6.93, p = 0.01; CDR: df = 1, F = 16.87, p <
0.0001). There were no significant differences in the two groups in terms of
observed side effects except agitation, which was more common in the
placebo group (p = 0.03). CONCLUSIONS: Melissa officinalis extract is of
value in the management of mild to moderate Alzheimer's disease and has a
positive effect on agitation in such patients.
PMID: 12810768
Fre text: >
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1738567/?tool=pubmed
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