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DEPEND

CompletedPhase 1 / PHASE2

Dosage and Efficacy of Probucol-induced apoE to Negate Cognitive Deterioration

Dose-finding and Proof-of-concept Trial of Probucol to Increase Availability of CSF Apolipoprotein-E

Asset

Probucol

Listed sites

1

Recruiting sites

-

Enrollment

23

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age 55-80

Primary endpoints

•Plasma concentration of probucol following test dose•Apolipoprotein concentration in CSF before and after treatment

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

Org study IDDEPEND
NCT IDNCT02707458

Timeline

Milestones

Study first posted2016-03-14estimated
Study start2016-04 (month precision)
Primary completion2017-03actual (month precision)
Study completion2017-03actual (month precision)
Last update posted2018-01-31actual

Assets

Drug assets

Probucol

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Family history of one or more parents or multiple siblings who developed Alzheimer-like dementia, as established by review of history and/or medical records, and by responses to a brief questionnaire describing characteristics of the relatives' condition
•Aged 60+. May be aged 55-59 only if at least one parent or sibling experienced onset of Alzheimer's dementia at an age no more than 15 years beyond the prospective participant's current age
•At least six years of formal education
•Sufficient fluency in spoken and written English and/or French to participate in study visits and in psychometric testing
•A collateral respondent available to provide information on the cognitive and health status of the participant, and to assist with monitoring of study interventions, if needed
•Willingness to undergo four lumbar punctures for collection of CSF
•Affirmation of prior informed consent to undergo genetic testing for APOE and other known or suspected AD risk factors
•Ability and intention to participate in study visits per protocol, in the opinion of a study physician
•Willingness to limit use of over-the-counter or prescription medicines (e.g., tricyclic antidepressants, anti-histamines) known to prolong QTc interval, or to potentiate the tendency of probucol to prolong this interval, in the opinion of a study physician
•If on a statin or other lipid lowering drug that, in the opinion of a study physician, can safely be co-administered with probucol, willingness to remain on a stable dose of this medication during the entire trial period.
•Provision of informed consent for this trial

Exclusion criteria

•Known or identified cognitive disorder diagnosed previously by a physician, psychologist, nurse-clinician, or other health care provider, or by StoP-AD staff
•Past or present use of a commercially available acetyl-cholinesterase inhibitor including tacrine, donepezil, rivastigmine, or galantamine
•Past or present use of memantine or other approved cognitive enhancement prescription agent
•History of heart disease, myocardial infarction or documented acute coronary syndrome, or arrhythmia (including atrial fibrillation)
•Corrected QT interval using Bazett's formula (QTcB) interval > 450 msec for males or 470 msec for females as detected by EKG and confirmed by consultant cardiologist
•Clinically significant hypertension, anemia, liver disease, or kidney disease, in opinion of a study physician (participants with treated hypertension who are normotensive as a result of intervention may be enrolled.)
•Concurrent use of over-the-counter or prescription medicines (e.g., tricyclic antidepressants, anti-histamines) known to prolong QTc interval, or to potentiate the tendency of probucol to prolong this interval, in the opinion of a study physician
•Any inflammatory or chronic pain condition that necessitates regular use of opiates (e.g., oxycodone, hydrocodone, tramadol, meperidine, hydromorphone), or NSAIDs (more than 4 doses / week)
•Current plasma creatinine > 132 mmol/l (1.5 mg/dl)
•Current alcohol, barbiturate or benzodiazepine abuse or dependence (in opinion of study physician)
•Any other medical condition that, in the opinion of a study physician, makes it inadvisable for the participant to be assigned to regular dosage of probucol
•Enrolment in any trial or experimental protocol that, in the opinion of a study physician, is likely to interfere with PREVENT-AD or any of its derivative protocols including this one
•Any other condition that, in the opinion of a study physician, makes it medically inappropriate for the participant to enroll in the program

Endpoints (2)

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.

Fluid / digital biomarkers

2 endpoints
Primary/protocol endpoint

Plasma concentration of probucol following test dose

Time frame:three months

threshold achievement, improvement

Primary/protocol endpoint

Apolipoprotein concentration in CSF before and after treatment with probucol at individualized dose

Time frame:One year on individualized dosing, as suggested by experimental observations above

threshold achievement, improvement

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.