European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
2 other identifiers
interventional
40
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2006
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedAugust 21, 2008
August 1, 2008
2.1 years
July 26, 2006
August 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
June 2008
Secondary Outcomes (2)
Validate biochemical markers relevant to Alzheimer's disease
June 2008
Assess the suitability of chosen HF0220 dose levels for future studies
June 2008
Study Arms (4)
Group1
PLACEBO COMPARATOR4x 7 day rising dose
Group2
PLACEBO COMPARATOR4x, 7 day rising dose
Group3
PLACEBO COMPARATOR28 day fixed lower dose
Group4
PLACEBO COMPARATOR28 day fixed upper dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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, S205D2, Sweden
Karolinksa Institute
Stockholm, SE14186, Sweden
Research Institute for Care of the Elderly
Bath, BA2 5RP, United Kingdom
Memory Assessment and Research Centre
Southampton, SO30 3JB, United Kingdom
Kingshill Research Centre
Swindon, SN1 4HZ, United Kingdom
Related Publications (1)
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.
PMID: 12859344BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Wilkinson
Chief Principal Investigator
- PRINCIPAL INVESTIGATOR
Niels Andreasen, Dr
Swedish Co-Ordinating Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 21, 2008
Record last verified: 2008-08