European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357357
• Other study ID #: HF0220/003
• Secondary ID: 2005-005791-32
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2006
• Last updated: August 20, 2008
• Start date: July 2006
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Hunter-Fleming Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• HF0220
comparison of different dosages of drug

Locations

Country	Name	City	State
India	Manipal Hospital,	Bangalore	Karna
India	Madras Medical College & Government General Hospital	Chennai	Tamilnadu
India	Nizam's Institute of Medical Sciences,	Hyderabaad	Panjagutta
India	Sree Chitra Tirunal Institute for Medical Sciences and Technology	Thiruvananthapuram	Kerala
India	King George Hospital	Visakhapatnam	Andh Prad
Sweden	Malmo University Hospital	Malmo
Sweden	Karolinksa Institute	Stockholm
United Kingdom	Research Institute for Care of the Elderly	Bath
United Kingdom	Memory Assessment and Research Centre	Southampton
United Kingdom	Kingshill Research Centre	Swindon

Sponsors (1)

Lead Sponsor	Collaborator
Hunter-Fleming Ltd

Countries where clinical trial is conducted

India,  Sweden,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients		June 2008	Yes
Secondary	Validate biochemical markers relevant to Alzheimer's disease		June 2008	No
Secondary	Assess the suitability of chosen HF0220 dose levels for future studies		June 2008	Yes