Alzheimer's Disease MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Intuniv
Product Name: Intuniv
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out whether the addition of extended release guanfacine (GXR) to standard therapy in Alzheimer's disease is 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 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 Assessment Scale- Cognition). This is the standard measure of cognition for trials of therapeutic agents in Alzheimer's Disease.;Timepoint(s) of evaluation of this end point: 12 weeks (and 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 4 weeks and 12 weeks (Safety measures will be tested at these points and also at 1 week and 8 weeks);Secondary end point(s): Secondary outcome measures are specific tests of attention and performance of activities of daily living: Tests of Attention Trails A and B The trail-making test is one of the most widely used in neuropsychology. Both parts consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 – 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 – 13) and letters (A – L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Digit-Symbol Substitution The test requires the subject to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. It is scored by totaling the number of successful transcriptions during 60s, and is a measure of processing speed. Test of Everyday Attention-Map Search and Elevator Counting In the map search subtest, which is a test of selective attention, participants search for symbols on a coloured map. The score is the number out of 80 found in 2 minutes. This subtest is age-sensitive and usable with almost all braindamaged patients, including those with Alzheimer’s disease. It measures selective attention. In the ‘Elevator Counting with Distraction’ subtest, subjects have to count the low tones in a pretend elevator while ignoring the high tones. This is a test of auditory selective attention. CANTAB-RVP THE RVP (Rapid Visual Information Processing) | — |
Countries
United Kingdom
Contacts
Public ContactParesh Malhotra
Imperial College London
Outcome results
None listed