Status:
COMPLETED
European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
Lead Sponsor:
Hunter-Fleming Ltd
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate bio...
Eligibility Criteria
Inclusion
- RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES
- INCLUSION CRITERIA:
- Participants must meet the following inclusion criteria to be eligible.
- Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study.
- A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification.
- Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24.
- Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment.
- Written consent should be obtained from the patient and responsible carer.
- EXCLUSION CRITERIA
- Patients will not be eligible to participate in the study if they meet any of the following criteria:
- Primary, secondary or pseudodementias other than probable Alzheimer's disease.
- Clinically significant and/or uncontrolled condition or other significant medical disease.
- If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment.
- Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity.
- Non-steroidal or steroidal anti-inflammatory agents. However, patients stable on low dose aspirin (upto 300mg/day) for at least 3 month prior to enrolment will be eligible.
- Taking anti-oxidant supplements.
- Active smokers of tobacco.
- Considered to be malnourished (body mass index \<19).
- Patients in whom a lumbar puncture is contra-indicated.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00357357
Start Date
July 1 2006
End Date
August 1 2008
Last Update
August 21 2008
Active Locations (10)
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1
King George Hospital
Visakhapatnam, ANDH PRAD, India
2
Manipal Hospital,
Bangalore, Karna, India
3
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India
4
Nizam's Institute of Medical Sciences,
Hyderabaad, Panjagutta, India