A Trial of Long-Acting Guanfacine in addition to Standard Therapy in Mild to Moderate Alzheimer's Disease

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002598-36-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-13
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

NINCDS/ADRDA criteria for probable AD
MMSE at assessment = 10-30.
Identified informant to accompany patient at all visits
Patient must have been on stable dose of donepezil, galantamine or rivastigmine for preceding 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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 is
130)) OR Both ALT and total bilirubin > ULN OR Total bilirubin > 60 (ULN is 30) ; Severe Renal Impairment (eGFR<40)
(Lower Limit of Normal is 59)
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 (In order to ensure that an excessive dose per body weight is not used in the study).
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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To find out whether the addition of extended release guanfacine (GXR) to standard therapy in Alzheimer's disease is<br>beneficial (improves thinking) in comparison to standard therapy on its own.;Secondary Objective: To find out whether combined treatment (GXR + standard therapy) is more effective in patients with mild or moderate<br>Alzheimer's Disease;Primary end point(s): The primary outcome measure for the study is cognition as measured by the ADAS-Cog (Alzheimer’s Disease<br>Assessment Scale- Cognition). This is the standard measure of cognition for trials of therapeutic agents in<br>Alzheimer's Disease.;Timepoint(s) of evaluation of this end point: 12 weeks (and 4 weeks)