Skip to main content
Delfa

← Trials/Trial dossier/NCT00766363

CompletedPhase 1Results posted

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase 1b Safety Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Patients With Mild to Moderate Probable Alzheimer's Disease

Assets

Donepezil / EVP-6124 / Rivastigmine

Listed sites

4

Recruiting sites

-

Enrollment

49

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 18-26

Primary endpoint

•Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo

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-6124-007
NCT IDNCT00766363

Timeline

Milestones

Study start2008-10 (month precision)
Study first posted2008-10-03estimated
Primary completion2009-03actual (month precision)
Study completion2009-03actual (month precision)
Results first posted2011-07-14estimated
Last update posted2012-04-20estimated

Assets

Drug assets

DonepezilEVP-6124Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•male and post-menopausal or surgically sterile female pts
•50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease (Mini-Mental State Examination of 18-26; Hachinski Ischemic Score ≤4)
•must be taking donepezil or rivastigmine for at least 3 mos

Exclusion criteria

•Unstable medical condition that is clinically significant in the judgment of the investigator; major organ system dysfunction
•Untreated hypothyroidism
•Insufficiently controlled diabetes mellitus
•Diagnosis of major depression requiring antidepressant medications within the last 5 years
•Stroke within 6 months before screening, or concomitant with onset of dementia
•Certain concomitant medications

Endpoints (20)

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.

Safety / tolerability / PK

20 endpoints
Primary/protocol endpoint

Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease

Time frame:Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]

descriptive

Primary/registry result

Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease

Time frame:Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]

descriptive

Posted result

GroupValue (number), ParticipantsReported bounds
EVP-6124 (0.1 mg/Day)Serious Adverse Eventsn=12 Participants0-
Non-Serious Adverse Eventsn=12 Participants2-
No Adverse Events Reportedn=12 Participants10-
EVP-6124 (0.3 mg/Day)Serious Adverse Eventsn=13 Participants0-
Non-Serious Adverse Eventsn=13 Participants3-
No Adverse Events Reportedn=13 Participants10-
EVP-6124 (1.0 mg/Day)Serious Adverse Eventsn=11 Participants0-
Non-Serious Adverse Eventsn=11 Participants4-
No Adverse Events Reportedn=11 Participants7-
PlaceboSerious Adverse Eventsn=13 Participants0-
Non-Serious Adverse Eventsn=13 Participants4-
No Adverse Events Reportedn=13 Participants9-
Secondary/protocol endpoint

EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Secondary/protocol endpoint

EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Secondary/protocol endpoint

EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Secondary/protocol endpoint

Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Secondary/protocol endpoint

Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Secondary/protocol endpoint

Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Secondary/protocol endpoint

Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Secondary/protocol endpoint

Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Secondary/protocol endpoint

Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Secondary/registry result

EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=12 Participants0.07150.0121
EVP-6124 (0.3 mg/Day)n=13 Participants0.19110.0740
EVP-6124 (1.0 mg/Day)n=10 Participants0.61220.1235
Secondary/registry result

EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Posted result

GroupValue (mean), hoursStandard deviation
EVP-6124 (0.1 mg/Day)n=12 Participants7.703.31
EVP-6124 (0.3 mg/Day)n=13 Participants7.943.61
EVP-6124 (1.0 mg/Day)n=10 Participants10.726.69
Secondary/registry result

EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=12 Participants1.310.23
EVP-6124 (0.3 mg/Day)n=11 Participants3.890.84
EVP-6124 (1.0 mg/Day)n=7 Participants11.442.24
Secondary/registry result

Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=10 Participants29.515.8
EVP-6124 (0.3 mg/Day)n=13 Participants24.719.8
EVP-6124 (1.0 mg/Day)n=7 Participants39.226.7
Placebon=13 Participants41.919.7
Secondary/registry result

Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Posted result

GroupValue (mean), hoursStandard deviation
EVP-6124 (0.1 mg/Day)n=10 Participants2.302.65
EVP-6124 (0.3 mg/Day)n=12 Participants1.852.15
EVP-6124 (1.0 mg/Day)n=7 Participants3.313.01
Placebon=13 Participants3.564.02
Secondary/registry result

Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=10 Participants299179
EVP-6124 (0.3 mg/Day)n=13 Participants240194
EVP-6124 (1.0 mg/Day)n=7 Participants345225
Placebon=13 Participants427233
Secondary/registry result

Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=2 Participants23.355.16
EVP-6124 (1.0 mg/Day)n=2 Participants3.510.37
Secondary/registry result

Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Time frame:24 hours

time to event, event

Posted result

GroupValue (mean), hoursStandard deviation
EVP-6124 (0.1 mg/Day)n=2 Participants1.000.02
EVP-6124 (1.0 mg/Day)n=2 Participants12.1215.72
Secondary/registry result

Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Time frame:24 hours

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
EVP-6124 (0.1 mg/Day)n=2 Participants143.5585.52
EVP-6124 (1.0 mg/Day)n=2 Participants54.606.28

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.