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LM11A-31-BHS

Phase II trials

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Study Information

Scientific title

Study of LM11A-31-BHS in patients with mild to moderate probable Alzheimer's disease

Study sponsor

PharmatrophiX Inc.

Disease

Alzheimer’s disease

Phase

Phase IIa

Information about the drug that will be tested in the study

Name of drug

LM11A-31-BHS

Administration

Two capsules taken twice daily (morning/evening)

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

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

  • One capsule of 200mg of LM11A-31-BHS and one capsule of placebo (an inactive substance identical in appearance to the drug being tested)
  • Two capsules of 200mg of LM11A-31-BHS
  • Two capsules of placebo.

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 purpose of the study is to evaluate the safety of LM11A-31-BHS in people with Alzheimer’s disease.

How long will the treatment last? 

6 months (5 study visits).

What will your involvement entail?

  • Complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study
  • Participants will be asked to undertake CSF examination (spinal tap) to see change in amyloid and tau deposition in the brain
  • During the study, participants will be asked to complete different tests that will assess their cognition, memory and verbal fluency.

Further information on the procedures can be obtained from the study team. 

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be 50 to 85 years old (or be 50 to 80 years old in Czech Republic)
  • Have a diagnosis of Alzheimer’s disease according to McKhann criteria
  • Have results of brain scans consistent with the clinical diagnosis of Alzheimer’s disease
  • Have evidence of abnormal accumulation of amyloid and tau in their brain (as per results of CSF examination (spinal tap))
  • Have a score between 18 and 26 points in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
  • Have a score ≤4 in the Rosen Modified Hachinski Ischemic test (a test used to differentiate types of dementia). This would suggest that dementia is not likely to be due to vascular causes
  • At least have 8 years of education
  • Have a study partner who has a sufficient contact with the participant, provides the necessary information about the participant’s memory, behaviour and functioning and, if necessary assure the administration of the drug
  • If the person is taking medication, the dosing regimen must have been stable for at least one month prior to the screening visit
  • If the person is taking acetylcholinesterase inhibitors as an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine) the dosing regimen must have been stable for at least 3 months prior to the screening visit.

Who cannot participate in the study?

Exclusion criteria include:

  • Hospitalization or change of chronic medication within the past month
  • Any evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, other neurodegenerative disease or infections with neurological involvement)
  • A clinically significant psychiatric disorder
  • A disease that may interfere with the safety or study assessments including uncontrolled diabetes, cancer and liver or heart diseasesWomen of childbearing potential
  • A current daily treatment with benzodiazepines, neuroleptics, antiepileptics or anti-hypertensive drugs
  • History of alcohol or drug abuse
  • Have participated in a recent clinical study.

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
  • Czech Republic
  • Germany
  • Spain
  • Sweden

Estimated start date of recruitment

February 2017

Information for your doctor

EudraCT Number

2015-005263-16

Clinicaltrials.gov identifier

NCT03069014

Study contact information

Nikola Helmberg:

  • nhelmberg@neuroscios.com
  • 0043 3132 40444 12

Ines Grieshuber:

  • igrieshuber@neuroscios.com
  • 0043 3132 40444 14

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03069014

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on April 2019.

The pharmaceutical company running this trial has reviewed this document.

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

 

 
 

Last Updated: Friday 26 April 2019

 

 
 

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