European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
NCT ID: NCT00357357
Last Updated: 2008-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2006-07-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group1
4x 7 day rising dose
HF0220
comparison of different dosages of drug
Group2
4x, 7 day rising dose
HF0220
comparison of different dosages of drug
Group3
28 day fixed lower dose
HF0220
comparison of different dosages of drug
Group4
28 day fixed upper dose
HF0220
comparison of different dosages of drug
Interventions
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HF0220
comparison of different dosages of drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
No
Sponsors
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Hunter-Fleming Ltd
INDUSTRY
Responsible Party
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Hunter-Fleming Ltd
Principal Investigators
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David Wilkinson
Role: PRINCIPAL_INVESTIGATOR
Chief Principal Investigator
Niels Andreasen, Dr
Role: PRINCIPAL_INVESTIGATOR
Swedish Co-Ordinating Principal Investigator
Locations
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King George Hospital
Visakhapatnam, ANDH PRAD, India
Manipal Hospital,
Bangalore, Karna, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India
Nizam's Institute of Medical Sciences,
Hyderabaad, Panjagutta, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, India
Malmo University Hospital
Malmo, , Sweden
Karolinksa Institute
Stockholm, , Sweden
Research Institute for Care of the Elderly
Bath, , United Kingdom
Memory Assessment and Research Centre
Southampton, , United Kingdom
Kingshill Research Centre
Swindon, , United Kingdom
Countries
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References
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Pringle AK, Schmidt W, Deans JK, Wulfert E, Reymann KG, Sundstrom LE. 7-Hydroxylated epiandrosterone (7-OH-EPIA) reduces ischaemia-induced neuronal damage both in vivo and in vitro. Eur J Neurosci. 2003 Jul;18(1):117-24. doi: 10.1046/j.1460-9568.2003.02734.x.
Other Identifiers
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2005-005791-32
Identifier Type: -
Identifier Source: secondary_id
HF0220/003
Identifier Type: -
Identifier Source: org_study_id