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NorAD

UnknownPhase 3

Noradrenergic Add-on Therapy With Guanfacine

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

Asset

Guanfacine

Listed sites

1

Recruiting sites

-

Enrollment

148

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-30•AD symptomatic therapy: stable ≥12 weeks

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIRAS 171996
NCT IDNCT03116126

Timeline

Milestones

Study first posted2017-04-14actual
Study start2019-01-04actual
Last update posted2024-05-13actual
Primary completion2024-08-05estimated
Study completion2024-08-05estimated

Assets

Drug assets

Guanfacine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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)

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Executive function / language
2
Behavior / neuropsychiatric
2
Global cognition
1
Function / daily living
1
Other clinical outcomes
1

Global cognition

1 endpoint
Primary/protocol endpoint

Cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

Time frame:12 weeks

ADAS-Cog

descriptive

Executive function / language

2 endpoints
Secondary/protocol endpoint

Tests of Attention: Trails A and B

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Test of Everyday attention

Time frame:12 weeks

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)

Time frame:12 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

event count, event

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Zarit Burden Interview (22 Item)

Time frame:12 weeks

event count, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Blood pressure

Time frame:12 weeks

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Digit-symbol substitution

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

CANTAB-RVP

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Epworth Sleepiness Scale

Time frame:12 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.