Cerebrolysin: a forward thinking way to treat Alzheimer’s disease

Alzheimer’s disease affects many millions of people worldwide. Currently, Alzheimer’s disease treatments only target the symptoms.

Cerebrolysin is part of a new and extensively clinically tested approach to treating this debilitating disease. Instead of trying to inhibit an enzyme that destroys neurotransmitters in the brain when Alzheimer's disease is contracted, Cerebrolysin targets the causes.

Working to improve the function and the quantity of neurons and brain transmitters, Cerebrolysin not only decreases the rate at which brain cells die, it’s known to block exitocins – now believed to be one of the main causes of Alzheimer's disease.

In short, by addressing the causes, Cerebrolysin works to block and slow the onset of Alzheimer's disease preventatively.

What is Alzheimer’s disease?

In most cases, Alzheimer's disease symptoms are characterised by a loss of mental facilities that go far beyond the sufferer’s ability to recall facts, memories and maintain normal body functions. It’s well known that Alzheimer's disease not only affects the person with the condition but can also causes distress to those people around the sufferer – by not being able to remember loved ones and relatives, and eventually having to have professional care arranged – costly both financially and emotionally.

It affects a growing aging population, and it’s currently estimated that around 25 – 30 million people worldwide have been diagnosed with the disease. It’s particularly present in older people where it’s known that one in five people over the age of 60 will have Alzheimer’s disease.

The causes of Alzheimer’s disease are being explored by scientists and doctors continually, but the main theory put forward is that the disease affects neurotransmitters and the way brain cells communicate with each other.

How traditional Alzheimer’s disease treatments work

Post-mortem studies have revealed that those with Alzheimer disease had a lower level of the brain neurotransmitter – Acetylcholine.

The enzyme that breaks down acetycholine function is therefore targeted by established drugs - like Donepezil (brand name Aricept®). This is a way of trying to slow down the damage to cells that are already diminished or damaged by the onset of the disease.

How cerebrolysin works

By looking at the everyday causes of Acetylcholine breakdown – and by looking at the way the drug Memantine works – it’s clear that excitoxins which damage the neurotransmitters may play a role in the progression of Alzheimer's disease.

Excitoxins can be linked to our diets – for example the presence of MSG or the sugar substitute, aspartate, in our foods. So if we deal with the damaging excitoxins, we can help the brain cells avoid attack in the first place.

Not only does Cerebrolysin prevent damage, it also appears to help support and maintain neurons including: serotonin, choline (related to Acetylcholine) and noradrenaline.

Cerebrolysin (or CRB) appears to also affect synaptic responses in the hippocampus - the region of the brain responsible for functions of memory. In short; using cerbrolysin helps maintain vital repair processes and prevents damage to the Acetylcholine receptor groups in the brain.

Proven efficacy

In over 80 clinical trials with over 5000 patients with mild to moderate cases of the condition, using Cerebrolysin was found to significantly improve cognitive powers. Taken by I.V (intravenously) and by I.M (via a muscle) the tests also showed continued effects: even after 4 weeks, patients remained stable for up to six months after stopping the therapy.

With the exception of the possibility of any mild side effects from an injection (like dizziness), there are no known side effects, and Cerebrolysin is derived naturally. A normal dose is about a 5ml ampoule injected either in the muscle or in the vein each day for 5 days, then repeated for a period of 4 weeks. After a 2 month treatment break, the cycle is repeated. This means that with Cerebrolysin price is key – 4 packets would be enough for 1 month at a time. Not only does the treatment work to prevent Alzheimer’s disease, but it strengthens the neurons and neurotransmitters in the brain which improves the overall function.

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Label

CEREBROLYSIN®

5ml ampoules

For the modern, safe and effective treatment of disturbed cerebral functions

COMPOSITION

Cerebrolysin® is a peptide preparation. The solution, ready for injection or infusion, is free of proteins, lipids and antigenic properties. 1ml of Cerebrolysin® concentrate as active ingredient in aqueous solution.

ROUTE OF ADMINISTRATION

Solution for intramuscular and intravenous injection or intravenous infusion.

Pharmacodynamics

The efficacy of Cerebrolysin® is proven in numerous animal experiments and clinical trials. Cerebrolysin® is a brain-specific peptidergic nootropic drug able to affect the central nervous system in a multimodal way. This multimodal action of Cerebrolysin® expresses itself as : 1) regulation and improvement of the neuronal metabolism which prevents lactacidoses in hypoxic or ischaemic episodes, 2) modulation of the synaptic plasticity which corresponds to an improvement of behaviour and learning capacity, and 3) a completely unique neurotrophic effect , including neuronal differentiation, guaranteeing full neuronal function and protection against different types of ischaemic and neurotoxin lesions .

In Controlled clinical trials Cerebrolysin® treatment leads to an improvement in the cognitive performance and mood of patients suffering from Alzheimer’s disease. Therefore, the amount of care needed by these sufferers decreases. In these patients marked improvement is observed in 61.7% of the

Cerebrolysin® - treated group (as assessed by the Clinical Global Impressions scale CGI ). Another clinical trial in patients with vascular dementia demonstrates enhancement of memory performance in the group receiving Cerebrolysin® treatment. An improvement in the global clinical picture is also noticed in this illness. A further study involving patients from nine different disease entities established the effectiveness of Cerebrolysin® through the use of 11 psychological tests subjected to a variance analysis.

After stroke and craniocerebral truma treatment with Cerebrolysin® leads to an accelerated recovery.

Literature on Cerebrolysin® is available upon request.

Pharmacokinetics

cerebrolysin® passes through the blood-brain barrier . Up to eight hours after iv administration of Cerebrolysin® neurotophic activity can be detected in the human long-lasting effects even after a single iv administarion.

Toxicological properties

Cerebrolysin® is generally well tolerated and possesses an extremely high margin of safety. In human therapeutic dosages this produces almost no toxic symptoms. The toxicological data are listed below. Acute toxicity: after a single iv administration of Cerebrolysin® the following LD50 values were observed (14 days observation period) :male rats68ml/kg body weight , female rats 74ml/kg body weight ; dogs, male and female >52.2ml/kg body weight. Chronic toxicity (multiple doses over six months) rats received up to 12.5ml/kg body weight daily for 26 weeks. Only moderate changes in the blood count were observed, dogs ; the highest administrated doses were 9ml/kg body weight daily for 28 days (about 10 times the human therapeutic dosage) and 4.5ml/kg body weight daily for 26 weeks (about five times the human therapeutic dosage): no systemic substance-dependent intolerance reactions were observed .

Reproductive toxicity

Cerebrolysin® was injected iv to the dams at the highest possible volumes: in no case was an alteration of the gestagenic period observed, in rabbits. Neither embryotoxic nor teratogenic effects nor impairments of embryonic or neonatal developments were found; no influence on the progeny (F1 and F2 generations) was evident. Influence on the fertility and reproductive performance of the parent animals potential, effect or carcinogenicity in toxicological tests, neither in vitro nor in vivo.

INDICATIONS

• disturbances of concentration and memory

• degenerative dementias, including Alzheimer’s disease

• vascular demenatias, eg multi-infarct dementia

• mixed forms of dementia (degenerative and vascular contribution)

• sequels of stroke (ischaemic and haemorrhagic)

• posttraumatic or postoperative complaints, eg following cerebral

contusion, concussion, or neurosurgical operation.

Contraindications

• hypersensitivity to one of the components of the drug

• status epilepticus or grand mal conulsions; an increase in the seizure

frequency may be seen in these cases

• status epilepticus or grand mal conulsions; an increase in the seizure

frequency may be seen in these cases

• severe impairments of renal function

SIDE EFFECTS

Cerebrolysin® is generally well tolerated. If injected too fast it may cause a moderate heat sensation. In extremely rare cases a hypersensitivity reaction manifested itself as chills, headaches or as slight increase in body temperature the cause of which is probably the hyperresponiveness of the patient. In no case to date has the undesirable effect persisted or proved threatening to the patient.

Warning and precautionary measures

Patients with severe renal impairment must be excluded from a Cerebrolysin® therapy. Animal experimental data did not show any evidence to teratogenic effects. There is no clinical experience with Cerebrolysin® in women. Therefore, unless the potential benefits outweigh any potential risk. Cerebrolysin® should not be administered during preguancy and the lactation period.

Interactions

The concomitant administration of Cerebrolysin® with antidepressive drugs or MAO inhibitors can lead to cumulative effects. In these cases a dose reduction of the antidepressive drug is advisable.

DOSAGE AND ADMINISTRATION

Cerebrolysin® is available in 1ml, 5ml and 10ml ampoules and vials of 30ml and 50ml. Up to 5ml per intramuscular administration, for administration over 5ml an intravenous injection or infusion is advised. Cerebrolysin® can also be given diluted in a standard iv solution (eg physiological saline solution, flinger’s solution, glucose 5%, dextran 40) infused slowly over approximately 20 to 60 minutes, Once daily application of Cerebrolysin® for a minimum of 10 to 20 days are recommended. This constitutes a course of therapy. In mild cases 1-5ml, in severe cases 10-30ml should be applied. The length of the therapy and the individual doses on the age of the patient as well as on the disease. Usually a treatment period of three to four weeks is recommended. Therapy courses can be repeated several times in accordance with the clinical picture of the patient until no further improvement can be observed. Therapy-free intervals should be maintained between courses. In severe cases it is advisable not to interrupt treatment abruptly but to continue with one injection every other day for a period of four weeks. From the above mentioned clinical trials the following daily dosage guits can be deducted dementias 3-50ml daily, in postapplectic deficits and brain injuries 10-50ml daily.

PRESENTATION AND PACKS

Original packs with 10 ampoules of 1ml

Original packs with 5 ampoules of 5ml

Original packs with 5 ampoules of 10ml

Original packs with 5 vials of 30ml

Original packs with 5 vials of 50ml

Storage

Keep in a safe place out the reach of children.

Store at room temperature not over 25°C, away from light.

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