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NorAD study

Phase III trials

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Study Information

Name of the study

Randomised Clinical Trial of Noradrenergic Add-on Therapy With Extended-Release Guanfacine in Alzheimer's Disease

Study sponsor

Imperial College London

Disease

People with mild to moderate Alzheimer's disease

Phase

Phase 3

Information about the drug that will be tested in the study

Name of drug

Guanfacine

Administration

A tablet taken orally once a day

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

Yes, to treat Attention Deficit Hyperactivity Disorder (ADHD) in children

Will all participants receive the same drug

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

  • A tablet of 2 mg of Guanfacine
  • One placebo tablet (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested).

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 assess whether a medication called Guanfacine can improve thinking (particularly attention), in people with Alzheimer’s disease when given alongside other standard medication that are normally used in this condition (e.g. Donepezil, Rivastigmine or Galantamine).

How long will the treatment last?

12 weeks

What your involvement will entail?

  • During the screening visit, participants will be assessed to see whether they would be suitable for the study.
  • During the study, participants will need to attend five study appointments with the study team at the Charing Cross Hospital (London, UK). Two follow-up telephone calls will also be planned between visits.
  • At every visits, participants will be asked to:
    • complete different tests that will assess their memory and attention (with breaks in between)
    • complete some tests to evaluate the possible treatment side-effects (i.e. sleepiness, blood pleasure).

Further information on the procedures, tests and visits 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 45 years of age or older.
  • Have a diagnosis of probable Alzheimer’s disease through clinical and neuropsychological examination (NINCDS/ADRDA criteria).
  • Take one of the three main standard recommended medications (Donepezil, Galantamine or Rivastigmine) at a stable dose for preceding 12 weeks.
  • Be willing to complete a memory test (MMSE). To be able to participate, the score of this test should suggest that the participant has a cognitive impairment that is very mild, mild or moderate (i.e. score between 10-30).
  • Be willing to have a study partner.

Who cannot participate in the study?

Exclusion criteria include:

  • Labile blood pressure (blood pressure fluctuates far more than usual) or new antihypertensive medication (drugs to treat high blood pressure) started within 3 weeks.
  • Treatment with other medications known to potentiate experimental drug’s effects (e.g. antipsychotics).
  • A disease that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. cardiac heart block, severe renal impairment or severe hepatic impairment).
  • A medical or neurological condition that could impact on the cognition or on the performance of the participant on cognitive assessments:
    • Myocardial infarction (heart attack)
    • History of unexplained syncope (loss of consciousness and muscle strength) within the last 12 months.
  • Treatment with other medications known to potentiate experimental drug’s effects (e.g. antipsychotics).
  • Weight less than 45 kg.
  • Pregnancy.

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

  • UK

Estimated start date of recruitment

January 2019

Information for your doctor

EudraCT Number

2016-002598-36

Clinicaltrials.gov identifier

NCT03116126

Study contact informatio

020 3311 5228   

Memory.research@imperial.nhs.uk 

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03116126

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

This document has not been reviewed by the pharmaceutical company running this trial.

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

 

 
 

Last Updated: Tuesday 16 July 2019

 

 
  • Acknowledgements

    Alzheimer Europe's Clinical Trial Watch received funding under an operating grant from the European Union’s Health Programme (2014–2020).
  • European Union
 
 

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