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APECS study

Clinical Trials Watch

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Study Information

Name of the study

Efficacy and safety trial of Verubecestat (MK-8931) in participants with prodromal Alzheimer's disease 

Study sponsor

Merck

Disease

Amnestic mild cognitive Impairment / prodromal Alzheimer’s disease (people experiencing mild changes in memory and thinking abilities, enough to be noticed, but which do not interfere with everyday activities and functioning).

Information about the drug that will be tested in the study

Name of drug

Verubecestat (MK-8931)

Administration

A tablet taken once daily

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected at random to receive one of the following options:

  • One tablet of 12 mg of verubecestat
  • One tablet of 40 mg of verubecestat
  • One placebo tablet (a dummy treatment)

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The study consists of two parts, Part I and Part II.

The purpose of Part I is to assess the safety and effectiveness of the study drug (verubecestat). Part I of the study will last 2 years. In this part of the study some participants will receive the study drug and others the placebo.

Participants who complete Part I of the study may choose to participate in Part II, which is an extension study for up to an additional 5 years. In Part II of the study, all participants will receive verubecestat (i.e. during the second part of the study none of the participants will receive the placebo).

How long will the treatment last?

Part I of the study will last 2 years and Part II will last 5 years.

What will your involvement entail?

During the study, participants will be asked to complete or undergo:

  • Tests that will assess their memory, orientation, judgment and problem solving, hobbies, personal care and community affairs, quality of life, etc.
  • Brain scans (MRI, PET) and a spinal tap (CSF, lumbar puncture). The spinal tap is optional.

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

To take part in the study, participants must:

  • Have noticed a decline in their memory, with slow progression, for at least one year.
  • The information about decline in memory has to be corroborated by an informant.
  • Have a reliable study partner / informant who has a close relationship with the participant, is willing to accompany the participant to all study visits, and to monitor that the medication is taken as ordered. 

Participants will be tested using a memory test at the screening visit, and results should indicate that the person:

  • Does not meet criteria for dementia.

 and

  • There is evidence of accumulation of a protein called amyloid in the brain (amyloid is consider to be a hallmark of Alzheimer’s disease). This can be seen in a brain scan (PET) or with a spinal tap (lumbar puncture, CSF). The spinal tap is optional.

If taking one of the approved anti-dementia drugs (i.e. donepezil, rivastigmine, galantamine or memantine) the dose must have been stable for at least three months before screening.

Who cannot participate in the study?

People cannot take part in the study, if they been diagnosed with or have:

  • History of stroke.
  • Relevant neurological disorder other than the disease being studied.
  • Seizures or epilepsy within the last 5 years.
  • A relevant or unstable psychiatric disorder, excluding major depression in remission.
  • Alcoholism or drug dependency/abuse within the last 5 years.
  • Hepatitis or liver disease that has been active within the last 6 months.
  • Uncontrolled, clinically significant medical condition in the last 3 months.
  • Cancer occurring within the last 5 years except for adequately treated skin cancer, in situ cervical cancer, or localized prostate carcinoma.
  • Clinically significant vitamin B12 or folate deficiency in the 6 months before screening.
  • Human immunodeficiency virus (HIV) by medical history.
  • Hypersensitivity reaction to more than three drugs

Individuals will not able to participate if they:

  • Are at imminent risk of self-harm or of harm to others
  • Have used any investigational drugs or participated in a clinical trial within the 30 days before screening
  • Have a close family member (including the trial partner, spouse or children) who is among the personnel of the investigational or sponsor staff directly involved in this study.
  • Don’t have a brain scan (MRI) obtained within 12 months of screening and are unwilling or not eligible to undergo an MRI scan at the screening visit. In some cases, with sponsor approval, a different type of brain scan (head computed tomography, CT) may be substituted for MRI scan to evaluate eligibility.
  • Are unwilling or is not safe for the person to undergo PET brain scan, including but not limited to claustrophobia, excessive weight or girth.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

  • Austria  
  • Belgium  
  • Finland  
  • France  
  • Germany 
  • Hungary
  • Italy
  • Netherlands 
  • Norway  
  • Spain  
  • Switzerland  
  • United Kingdom

Estimated start date of recruitment

November 2013

Completion date

July 2017

Information for your doctor

EudraCT Number:

2015-002134-49

Clinicaltrials.gov identifier

NCT01953601

Study contact information

michael.egan@merck.com

Link to full text

https://clinicaltrials.gov/ct2/results?term=NCT01953601&Search=Search

Study website

https://www.apecsstudy.com/#page3

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website).

The pharmaceutical company running this trial (Merck) has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 

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Last Updated: Wednesday 13 July 2016

 

 
 

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