Trials Sponsors Conditions Drugs Pricing

Conditions

Moderate Alzheimer's Disease

Keywords

Alzheimer's diseasecognitive impairmentcholinesterase inhibitorssustained-release implantslong acting treatment

Outcome Measures

Primary Outcomes (1)

Change in the MMSE score from baseline to week 25
baseline to week 25

Secondary Outcomes (5)

Responder rate as defined by at least 2 points improvement in the MMSE score;
baseline to week 25
Change on the ADAS-Cog 11 items subscale;
baseline to week 25
Change in the NPI-Q;
baseline to week 25
Change on the IADL scale;
baseline to week 25
Patient's convenience questionnaire.
baseline to week 25

Study Arms (2)

ZT-1

EXPERIMENTAL

ZT-1 (investigational product)

Drug: ZT-1

Donepezil

ACTIVE COMPARATOR

Donepezil

Drug: Donepezil

Interventions

ZT-1Drug

Patients in the ZT-1 treatment group will receive ZT 1-1 mg capsules administered p.o. daily during the first month of treatment, followed by ZT-1 implants (9 mg) administered s.c. during the second month of treatment, followed by ZT-1 implants (12 mg) administered s.c. every 4 weeks during months 3 to 6 of treatment. Patients in the ZT-1 treatment group will receive dummy donepezil capsules during months 2 to 6 of the treatment period.

ZT-1

DonepezilDrug

Patients in the donepezil treatment group will receive donepezil 5 mg capsules administered p.o. during the first month of treatment, followed by donepezil 10 mg/day during months 2 to 6 of the treatment period. Patients in the donepezil treatment group will also receive s.c. injections of dummy ZT 1 implants every 4 weeks during months 2 to 6 of the treatment period.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Presence of moderately severe probable AD, diagnosed according to the DSM-IV and the NINCDS-ADRDA criteria;
MMSE score ≥ 14 and ≤ 22;

Sponsors & Collaborators

Debiopharm International SA
Industrylead

Study Sites (28)

Central Coast Neuroscience Research

East Gosford, New South Wales, 2250, Australia

Hornsby-Kuring-gai Health Service

Hornsby, New South Wales, 2077, Australia

Southern Neurology

Kogarah, New South Wales, 2217, Australia

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

St George's Hospital

Kew, Victoria, 3101, Australia

Related Publications (1)

Wilkinson D, Roughan L. The BRAINz trial: a novel approach to acetylcholinesterase-inhibitor treatment for Alzheimer's disease. Future Neurol 2(4):379-382,2007.
BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Indans

Study Officials

Emmanuel Tamches, MD
Debiopharm SA
STUDY DIRECTOR

Enrollment

228 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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 visit 2 (Day 1) (or within 5 drug half-lives, whichever is longer) any medication listed as prohibited;
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 with ASAT, ALAT \>=3x the upper normal limit at screening;
Significant kidney impairment with serum creatinine \>=2x the upper normal limit at screening;
Presence of cardiac rhythm disorder, in particular bradycardia (\< 60 bpm), conduction abnormalities such as AV block; presence of active ischaemia (such as unstable angina pectoris) or recent myocardial infarction, QT interval ≥ 450 msec at screening, QRS complex ≥ 110 msec at screening (ECG must be within normal limits at screening);
Uncontrolled arterial hypertension i.e. patients with systolic blood pressure (BP) \>=160 mmHg and/or diastolic \>=100 mmHg, at screening despite regular medication;
Uncontrolled arterial hypotension, i.e. patients with systolic BP ≤ 100 mmHg and/or presenting a fall of systolic BP ≥ 20 mmHg or a fall of diastolic BP \>=10 mmHg after the 2 min Schellong test at screening;
Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or his/her participation to the study;
Participation in another study with an experimental drug within 3 months before study visit 2 (Day 1, baseline) or within 5 drug half-lives of the investigational drug (whichever is the longer);
Known peripheral cholinergic intolerance, i.e. with previously prescribed AChEI(s);
Known hypersensitivity to any of the test materials or related compounds, including lactose, present in the donepezil and placebo capsules;
Known active use of recreational drug or alcohol dependence, current alcohol abuse;
Inability to comply fully with the protocol;
Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason.

Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

ZT-1

Donepezil

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

ZT-1

Donepezil

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations