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TerminatedPhase 1

Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

A Double-blind, Randomized, Placebo-controlled, Phase I , Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

Asset

HPP854

Listed sites

3

Recruiting sites

-

Enrollment

7

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 20-26

Primary endpoint

•Number of Participant Adverse Events

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 IDHPP854-104
NCT IDNCT01482013

Timeline

Milestones

Study start2011-10 (month precision)
Study first posted2011-11-30estimated
Primary completion2012-03actual (month precision)
Study completion2012-03actual (month precision)
Last update posted2012-08-30estimated

Assets

Drug assets

HPP854

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Medical history for at least 6 months prior to screening of mild cognitive impairment with a Mini Mental State Exam (MMSE) score between 20 and 26 or diagnosis of mild Alzheimer's disease;
•Must be able to swallow dose of study medication;
•Body Mass Index (BMI) between 18.0 and 35.0; and
•Subject and Project Partner are willing to participate and agree to comply with all study requirements

Exclusion criteria

•Blood pressure > 160 mmHg (systolic) and > 90 mmHg (diastolic);
•Received HPP854 in a previous trial;
•Participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit.
•Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse;
•Clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder;
•History or presence of cancer except for non melanoma skin cancer. Subjects with a history of prostate cancer stable for > 3 yrs with no active treatment for > 3 years prior to Screening may be considered for eligibility;
•Use of the following medications/therapy from 14 days before dosing until after the Final Visit: anti-cholinergic, tricyclic antidepressants, lithium, typical or atypical antipsychotic medications, anticonvulsant medications, immunosuppressive agents, oral corticosteroids, and radiotherapy;
•HbA1C > 6.5 % at the Screening Visit;
•Vitamin B12 level < 211 pg/mL at the Screening Visit;
•Any suicidal risk determined by C-SSRS administered by a study staff member appropriately certified for administration of the scale (Baseline/Screening, Phase 1 Study Version) at Screening Visit, Day -6 or Day -1;
•A score of 15 or more on the modified Geriatric Depression Scale (GDS); and
•A score of 5 or more on the Hashinski Ischemic Scale (Rosen modification.
•Contraindications of MRI including: Metallic fragments, clips or devices in the brain, eye, spinal canal, etc; Cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants, etc.
•Contraindications for blood or CSF sampling, including: Bleeding disorder or taking anticoagulants/antiplatelet, chronic active infection.

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

Amyloid biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

Change in cerebrospinal fluid concentration of Amyloid-Beta

Time frame:Day -6 to Day 35

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participant Adverse Events

Time frame:Day 1 to Day 30

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Evaluation of participant plasma HPP854 concentrations

Time frame:Day 1 to Day 30

concentration, descriptive

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.