NCT03116126 · Phase 3 · ACTIVE NOT RECRUITING
Noradrenergic Add-on Therapy With Guanfacine
This Phase 3 trial is testing whether guanfacine, a long-acting drug already used for ADHD in children, can improve attention and thinking in people who already have Alzheimer's disease. Participants must already be taking a standard Alzheimer's medication like donepezil. Phase 3 means researchers are testing whether it actually works in a larger group — this is a serious, late-stage test, not early exploration.
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're excluded 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-05-13