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CompletedPhase 2

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

Lead sponsor

Hunter-Fleming Ltd

Asset

HF0220

Listed sites

10

Recruiting sites

-

Enrollment

40

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-24

Primary endpoint

•Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary2005-005791-32
Org study IDHF0220/003
NCT IDNCT00357357

Timeline

Milestones

Study start2006-07 (month precision)
Study first posted2006-07-27estimated
Primary completion2008-08actual (month precision)
Study completion2008-08actual (month precision)
Last update posted2008-08-21estimated

Assets

Drug assets

HF0220

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion 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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients

Time frame:June 2008

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Validate biochemical markers relevant to Alzheimer's disease

Time frame:June 2008

descriptive

Secondary/protocol endpoint/low confidence

Assess the suitability of chosen HF0220 dose levels for future studies

Time frame:June 2008

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.