Somasundaram  Panchanathan

Ambitious of being a clinical pharmacist , love to write a lot - looking forward to give good contents in medical field

ADUCANUMAB IN ALZHEIMERS - ITS EFFICACY AND FAQ

24 August 2021

ADUCANUMAB IN ALZHEIMERS - ITS EFFICACY AND FAQ

 

ABOUT THE DISEASE:

Alzheimer is a progressive neurodegenerative disease , it accounts for the sixth leading cause of death in US . The damage to the neurons are irreversible and it causes loss of memory and cognitive function . Alzheimers patients suffer demetia and lose their individuality. But so far the treatment options were limited and mostly there was only a symptomatic relief

 

PATHOLOGY :

Most common pathology associated with Alzheimers is the building of beta amyloid plaques and tangles which are tau proteins , plaques were formed outside the cell - The action of beta secretase which cleaves the amlyoid precausor protein which results in the formation of insoluable beta amyloid protien which are sticky by nature and results in the formation of beta amyloid plaques.These plaques prevent the transfer of signals from one neuron to the another thus causing impairment of memory and further symptoms.

 

ADUCANUMAB - ACCELERATED APPROVAL:

ADULHELM (ADUCANUMAB) is the first drug discovered in alzheimers disease to target the underlying pathophysiology . Since 2003 it was the first drug approved for alzheimers . Aducanumab was given a accelerated approval by FDA , the approval was based on the endpoint conducted in 3482 patients which is randomised ,placebo controlled study .End point indicated the reduction of beta amyloid plaques in brain which was assessed and quantified using PET(Positron Emission Tomography) .

Aducanumab is aintravenous injection administered once in a month , Aducanumab is a IgG1 (immunoglobulin) which acts as anti amyloid beta antibody whose primary target is amyloid beta aggregates.

 

ADUCANUMAB - TRIAL RESULTS

There were 3 studies conducted providing evidences of aducanumab use in alzheimers the trail names are Study 103 (NCT01677572) , Study 301 (NCT02477800) , STUDY 302 (NCT 02484547) respectively .

Study 103 the trial included 197 patients with dose inclanation of 10 mh / kg every 4 weeks , the results of the trial were that there were a dose and time dependent reduction of beta amyloid plaques.There was a marked improvement in scoring scales such as Dementia rating sum of boxes (CDRSB) and Mini mental status examination (MMSE).

In the other 2 studies (301 , 302) were a randomized double blinded placebo controlled study which included 1647 and 1638 in each study . In 301 there was a significant improvement in (CDR SB ) and other end points which included ( ADAS Cog 13 ) and MMSE at the approved high dose of 10 mg/kg . From the results Aducanumab fits the Fda accelerated approval criteria and meets the need of it.

 

ADDRESSING FAQ S :

 

DOES ADUCANUMAB CURE ALZHEIMERS ?

NO , It is the first drug which addresses the underlying pathology which gives increased time for the patient to perform activities independently.

 

WHAT IS THE INDICATION FOR ADUCANUMAB?

ADUCANUMAB can be used in patients with mild dementia only in patients with early alzheimers disease and mild cognitive impairment.

 

CAN ADUCANUMAB BRING BACK LOST MEMORIES?

There was no results about it during the study

 

WHICH DIAGNOSTIC TEST IS TO BE CONDUCTED TO INDICATE ADUCANUMAB IN ALZHEIMERS

The presence of beta amyloid plaques has to be confirmed before initiation of therapy , Diagnostic test include PET SCAN and cerebrospinal fluid analysis.

 

HOW TO ADMINISTER ADUCANUMAB

Aducanumab is a IV infusion given over 45-60 minutes given monthly , It should be done only in hospitals.

 

DOES ADUCANUMAB HAVE SIDE EFFECTS

Most common side effects are Headache , fall , severe allergic reaction (ARIA) Amyloid related imaging abnormality it is uncommo but serious adverse event with aducanumab. ARIA is a temprory swelling of the brain which can resolve on its own over time but sometimes it can result in unpleasant side effects such as head ache ,dizziness , nausea , confusion and vision changes.

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