Noradrenergic Add-on Therapy With Guanfacine (NorAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03116126|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : June 23, 2022
NorAD is a clinical trial funded by the UK National Institute of Health Research. In this trial the investigators will assess whether a long-acting preparation of guanfacine, a drug used to treat Attention Deficit Hyperactivity Disorder in children, can improve thinking (particularly attention) in Alzheimer's Disease when it is added to the standard NICE-approved drugs that are normally used in this condition.
This is a randomized clinical trial designed to evaluate the efficacy of extended-release guanfacine as an add-on therapy in AD, and whether it improves cognition compared to standard cholinergic therapy alone.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Guanfacine Drug: Placebo||Phase 3|
There is evidence suggesting that both noradrenaline and acetylcholine have key roles to play in attention. Guanfacine acts by increasing levels of noradrenaline, a substance in the brain which is closely linked with attention, both noradrenaline levels and attentional performance have been shown to be reduced in Alzheimer's Disease.
In this study the investigators propose that modulation of the noradrenergic deficit that has been described in Alzheimer's Disease in addition to standard cholinergic treatment could have significant positive effects on cognition, particularly in those patients who suffer from attentional impairments. The investigators want to assess whether long-acting guanfacine should be used in addition to NICE-approved drugs that are currently being used in AD as part of combination therapy.
It is a single-centre, randomised, parallel-group, double-blind controlled Phase 3 trial to compare the efficacy of standard cholinergic therapy (Donepezil, Rivastigmine or Galantamine) plus extended release guanfacine (2mg GXR) versus standard cholinergic therapy plus placebo on Cognition (as measured by the ADAS-Cog) in patients with mild to moderate Alzheimer's Disease.
The trial, which will recruit 160 patients (80 randomised to GXR add-on therapy and 80 randomised to placebo), based at Imperial College London - Imperial College Healthcare NHS Trust.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomised Clinical Trial of Noradrenergic Add-on Therapy With Extended-Release Guanfacine in Alzheimer's Disease|
|Actual Study Start Date :||January 4, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
|Active Comparator: Guanfacine||
2mg oral daily tablet
|Placebo Comparator: Placebo||
inactive oral daily tablet
- Cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) [ Time Frame: 12 weeks ]The ADAS-Cog is used to determine the extent of cognitive decline in AD. It is a common cognitive testing instrument in clinical trials consisting of 11 tasks measuring disturbances in memory, language, praxis, attention and other cognitive abilities that are core symptoms of AD.
- Tests of Attention: Trails A and B [ Time Frame: 12 weeks ]Neuropsychological test sensitive detecting cognitive impairment associated with dementia/AD.
- Digit-symbol substitution [ Time Frame: 12 weeks ]Neuropsychological test sensitive detecting cognitive impairment associated with dementia/AD.
- Test of Everyday attention [ Time Frame: 12 weeks ]Neuropsychological test sensitive detecting cognitive impairment associated with dementia/AD.
- CANTAB-RVP [ Time Frame: 12 weeks ]Neuropsychological test sensitive detecting cognitive impairment associated with dementia/AD.
- Neuropsychiatric Inventory (NPI) [ Time Frame: 12 weeks ]Examination and scoring of behavioural domains to determine the frequency and severity of behaviour with the patient and caregiver.
- Zarit Burden Interview (22 Item) [ Time Frame: 12 weeks ]Examination and scoring of behavioural domains to determine the frequency and severity of behaviour with the patient and caregiver.
- Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 12 weeks ]Examination and scoring of behavioural domains to determine the frequency and severity of behaviour with the patient and caregiver.
- Blood pressure [ Time Frame: 12 weeks ]Measure of side effects.
- Epworth Sleepiness Scale [ Time Frame: 12 weeks ]Measure of side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116126
|Imperial Memory Unit, Charing Cross Hospital||Recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Team 020 3311 5228 firstname.lastname@example.org|
|Principal Investigator:||Paresh Malhotra, MA BMBCh PhD||Imperial College London|