Clinical trial NCT00357357: European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
Official title: Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Hunter-Fleming Ltd
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
timeFrame: June 2008
Secondary outcomes:
measure: Validate biochemical markers relevant to Alzheimer's disease
timeFrame: June 2008
measure: Assess the suitability of chosen HF0220 dose levels for future studies
timeFrame: June 2008
Other outcomes:
Locations:
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andh Prad
city: Bangalore
country: India
facility: Manipal Hospital,
state: Karna
city: Thiruvananthapuram
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences and Technology
state: Kerala
city: Hyderabaad
country: India
facility: Nizam's Institute of Medical Sciences,
state: Panjagutta
city: Chennai
country: India
facility: Madras Medical College & Government General Hospital
state: Tamilnadu
city: Malmo
country: Sweden
facility: Malmo University Hospital
city: Stockholm
country: Sweden
facility: Karolinksa Institute
city: Bath
country: United Kingdom
facility: Research Institute for Care of the Elderly
city: Southampton
country: United Kingdom
facility: Memory Assessment and Research Centre
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre
Study officials:
affiliation: Chief Principal Investigator
name: David Wilkinson
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Co-Ordinating Principal Investigator
name: Niels Andreasen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.