Noradrenergic Add-on Therapy With Guanfacine
NorAD
Randomised Clinical Trial of Noradrenergic Add-on Therapy With Extended-Release Guanfacine in Alzheimer's Disease
1 other identifier
interventional
148
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 alzheimer-disease
Started Jan 2019
Longer than P75 for phase_3 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2024
CompletedMay 13, 2024
May 1, 2024
5.6 years
April 4, 2017
May 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
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.
12 weeks
Secondary Outcomes (9)
Tests of Attention: Trails A and B
12 weeks
Digit-symbol substitution
12 weeks
Test of Everyday attention
12 weeks
CANTAB-RVP
12 weeks
Neuropsychiatric Inventory (NPI)
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Guanfacine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Outpatients
- NINCDS/ADRDA criteria for probable AD
- MMSE at assessment = 10-30
- Identified informant to accompany patient at all visits
- Stable dose of donepezil, galantamine or rivastigmine for preceding 12 weeks
You may not qualify if:
- Labile blood pressure or new antihypertensive medication started within 3 weeks
- Severe coronary insufficiency or myocardial infarction in previous 6 months
- History of unexplained syncope within the preceding 12 months
- Cardiac Conduction Block
- Severe Hepatic Impairment (ALT \> 120 (Upper Limit of Normal (ULN) is 40) OR Alkaline Phosphatase \> 390 (ULN 130)) OR Both ALT and total bilirubin \> ULN OR Total bilirubin \> 60 (ULN 30)
- Severe Renal Impairment (eGFR \< 40)
- Treatment with other medications known to potentiate guanfacine's hypotensive effects or cause arrhythmia (specifically antipsychotics (including sultopride, chlorpromazine, thioridazine, amisulpiride, sulpiride, haloperidol), and moxifloxacin, baclofen, verapamil, quinidine, hydroquinidine, dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimazide, bepridil, cisapride, diphemanil, erythromycin, halofantrine, pentamidine, sparfloxacin, vincamine, alfuzosin, prazosin, terazosin, tamsulosin, amifostine
- Weight less than 45kg
- Pregnancy (Pre-menopausal women will only be entered into the study of they are surgically sterile or using effective birth control methods: These are abstinence for the period of the study, intrauterine contraception/device, male sexual partners with vasectomy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial Memory Unit, Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
Hoang K, Watt H, Golemme M, Perry RJ, Ritchie C, Wilson D, Pickett J, Fox C, Howard R, Malhotra PA. Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer's Disease (NorAD): study protocol for a randomised clinical trial and COVID-19 amendments. Trials. 2022 Aug 1;23(1):623. doi: 10.1186/s13063-022-06190-3.
PMID: 35915506DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paresh Malhotra, MA BMBCh PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 14, 2017
Study Start
January 4, 2019
Primary Completion
August 5, 2024
Study Completion
August 5, 2024
Last Updated
May 13, 2024
Record last verified: 2024-05