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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00357357
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : August 21, 2008
Sponsor:
Information provided by:
Hunter-Fleming Ltd

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: HF0220 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2006
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients [ Time Frame: June 2008 ]

Secondary Outcome Measures :
  1. Validate biochemical markers relevant to Alzheimer's disease [ Time Frame: June 2008 ]
  2. Assess the suitability of chosen HF0220 dose levels for future studies [ Time Frame: June 2008 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357357


Locations
India
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, Tamilnadu, India
Sweden
Malmo University Hospital
Malmo, Sweden, S205D2
Karolinksa Institute
Stockholm, Sweden, SE14186
United Kingdom
Research Institute for Care of the Elderly
Bath, United Kingdom, BA2 5RP
Memory Assessment and Research Centre
Southampton, United Kingdom, SO30 3JB
Kingshill Research Centre
Swindon, United Kingdom, SN1 4HZ
Sponsors and Collaborators
Hunter-Fleming Ltd
Investigators
Principal Investigator: David Wilkinson Chief Principal Investigator
Principal Investigator: Niels Andreasen, Dr Swedish Co-Ordinating Principal Investigator

Publications:
Responsible Party: Dr John Fox ,Chief Operations Officer, Hunter-Fleming Ltd
ClinicalTrials.gov Identifier: NCT00357357     History of Changes
Other Study ID Numbers: HF0220/003
2005-005791-32
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

Keywords provided by Hunter-Fleming Ltd:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders