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CompletedPhase 2

Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease

Safety, Tolerability, Pharmacokinetics, and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease

Asset

EVP-0962

Listed sites

1

Recruiting sites

-

Enrollment

52

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MCI due to AD

Primary endpoints

•Number of adverse experiences•Synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects•Concentration of Amyloid Beta in cerebral spinal fluid

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 IDEVP-0962-002
NCT IDNCT01661673

Timeline

Milestones

Study first posted2012-08-09estimated
Study start2012-11 (month precision)
Primary completion2013-10actual (month precision)
Last update posted2014-01-13estimated

Assets

Drug assets

EVP-0962

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age45 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Part 1: Male and female subjects between the ages of 45 to 65 (inclusive) in good health with a BMI of 18-32 kg/m2 and negative urine drug screen of abuse test.
•Part 2: Male and female subjects between the ages of 45 to 85 (inclusive), MRI/CT scans compatible with diagnosis of MCI or early AD, meets the classification of MCI due to AD as defined by the National Institute on Aging-Alzheimer's Association, and a BMI of 18-32 kg/m2(inclusive). Subjects must meet the following Cognitive criteria: Subject Memory Complaint, cognitive impairment in one or more areas, CDR-SB score less than or equal 1.0, MMSE greater than 24, and no impairment in social or occupational functioning

Exclusion criteria

•History of seizure disorder, symptomatic orthostatic hypotension, QTc values greater than 450 ms, positive drug screening tests
•Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
•C-SSRS suicidal ideation score of 4 or 5
•Unwilling to abstain from vigorous exercise
•Concurrent disease other than MCI or early AD that is attributing to patient's cognitive impairment.
•Lumbar spine X-rays show anatomic contraindications to lumbar puncture
•History of spinal surgery or chronic low back pain
•History of migraine headaches

Endpoints (5)

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
3
Safety / tolerability / PK
2

Amyloid biomarkers

3 endpoints
Primary/protocol endpoint

To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects

Time frame:0-36 hours post dose

descriptive

Primary/protocol endpoint

To measure the concentration of Amyloid Beta in cerebral spinal fluid

Time frame:0-36 hours post dose

concentration, descriptive

Secondary/protocol endpoint

To measure the rate of synthesis of Amyloid Beta and steady-state levels in the cerebral spinal fluid in MCI or early Alzheimer's disease patients

Time frame:0-36 hours post dose

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

The number of adverse experiences reported by subjects and/or observed by investigator and repeated clinical evaluations of physical examinations, vital signs, 12-lead ECG (electrocardiogram), and lab tests (hematology, chemistry, urinalysis)

Time frame:Screening (Day-45 to Day -1) through Day 23 (end of study visit)

event count, event

Secondary/protocol endpoint

To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma

Time frame:0-36 hours post dose

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.