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

August 20, 2008 updated by: Hunter-Fleming Ltd

Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andh Prad
      • Visakhapatnam, Andh Prad, India
        • King George Hospital
    • Karna
      • Bangalore, Karna, India
        • Manipal Hospital,
    • Kerala
      • Thiruvananthapuram, Kerala, India
        • Sree Chitra Tirunal Institute for Medical Sciences and Technology
    • Panjagutta
      • Hyderabaad, Panjagutta, India
        • Nizam's Institute of Medical Sciences,
    • Tamilnadu
      • Chennai, Tamilnadu, India
        • Madras Medical College & Government General Hospital
  • Sweden
      • Malmo, Sweden, S205D2
        • Malmö University Hospital
      • Stockholm, Sweden, SE14186
        • Karolinksa Institute
  • United Kingdom
      • Bath, United Kingdom, BA2 5RP
        • Research Institute for Care of the Elderly
      • Southampton, United Kingdom, SO30 3JB
        • Memory Assessment and Research Centre
      • Swindon, United Kingdom, SN1 4HZ
        • Kingshill Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group1
4x 7 day rising dose
Drug: HF0220
comparison of different dosages of drug
Placebo Comparator: Group2
4x, 7 day rising dose
Drug: HF0220
comparison of different dosages of drug
Placebo Comparator: Group3
28 day fixed lower dose
Drug: HF0220
comparison of different dosages of drug
Placebo Comparator: Group4
28 day fixed upper dose
Drug: HF0220
comparison of different dosages of drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
Time Frame: June 2008
June 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Validate biochemical markers relevant to Alzheimer's disease
Time Frame: June 2008
June 2008
Assess the suitability of chosen HF0220 dose levels for future studies
Time Frame: June 2008
June 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter-Fleming Ltd

Investigators

  • Principal Investigator: David Wilkinson, Chief Principal Investigator
  • Principal Investigator: Niels Andreasen, Dr, Swedish Co-Ordinating Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF0220/003
  • 2005-005791-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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