mild to moderate Alzheimer’s Disease (AD) MedDRA version: 7.0 Level: PT Classification code 10011762
Conditions
Interventions
Product Name: N-(5-chloro-2-hydroxy-3-methoxy-benzylidene)-huperzine A
Product Code: ZT-1
Pharmaceutical Form: Capsule*
CAS Number: 180694-97-7
Current Sponsor code: ZT-1
Other descriptive name: N-(5-
Sponsors
Debiopharm SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with mild to moderately severe probable AD, diagnosed according to the DSM-IV and the criteria of NINCDS-ARDRA. MMSE score at study entry ³12 and £ 26. Patients should be aged >60 years. Patients should be ambulatory and have a caregiver/informant willing to be present at each assessment. Subjects should be physically able to carry out functional tasks. Computed tomographic or magnetic resonance imaging to exclude other structural brain disease performed within 6 months before study start should support diagnosis of AD. Patients must provide a written informed consent together with the caregiver. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence of any disabling, severe or life-threatening disease (cardiac, respiratory, gastro-intestinal, neurological, epileptic, psychiatric, infectious, bone, endocrinologic). Inability to discontinue at least 2 weeks prior to study start any medication listed as prohibited (see section 7.5.2 Prohibited medications). Prior use of cholinesterase inhibitors. Proven or clinically suspected other type of dementia such as vascular dementia, post-traumatic dementia, fronto-temporal dementia, dementia associated with Parkinson’s disease, infectious disease, (HIV, syphilis) folate or vitamin B12 deficiency, hypothyroidism etc. Significant liver impairment : ASAT, ALAT ³ 3 times the upper normal limit. Presence of cardiac rhythm disorder, in particular bradycardia or conduction abnormalities (ECG within normal limits at prestudy). Uncontrolled arterial hypertension i.e. subjects with systolic BP ³160 mm Hg and/or diastolic ³100 mmHg, despite regular medication. Significant kidney impairment: serum creatinine ³ 2 times the upper normal limit. Any concomitant disorder or resultant therapy that is likely to interfere with subject compliance or with the study. Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer). Known hypersensitivity to any of the test materials or related compounds. Known active use of recreational drug or alcohol dependence, current alcohol abuse. Inability to give written informed consent together with the caregiver or to comply fully with the protocol. Subjects who, in the opinion of the Investigator, are considered unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerance of two ZT-1 dose levels (1.5 mg, 2 mg 1x/d) compared to placebo and donepezil in patients with mild to moderate AD ;Secondary Objective: To assess the efficacy of two ZT-1 dose levels (1.5 mg, 2 mg 1x/d) to improve cognitive function compared to placebo and donepezil in patients with mild to moderate AD To assess the efficacy of two ZT-1 dose levels (1.5 mg, 2 mg 1x/d) to improve behavioural, overall and functional outcomes compared to placebo and donepezil in patients with mild to moderate AD To measure plasma concentrations of ZT-1, its active metabolite huperzine A and its inactive metabolite 5-Cl-o-vanilline for a subsequent population pharmacokinetic analysis of pooled data to establish standard pharmacokinetic parameters ;Primary end point(s): (Co-primary endpoints:) Change in ADAS-cog conventional from pre-treatment to Week 12. Change in ADAS-cog extended version from pre-treatment to Week 12. | — |
Countries
United Kingdom
Outcome results
None listed