NCT00766363

Brief Summary

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 14, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

October 1, 2008

Results QC Date

June 16, 2011

Last Update Submit

April 18, 2012

Conditions

Alzheimer's DiseaseCentral Nervous System Diseases

Keywords

Alzheimer's DiseaseCentral Nervous System DiseasesPharmacokineticsCognition

Outcome Measures

Primary Outcomes (1)

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

    All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)

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

Secondary Outcomes (9)

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

    24 hours

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

    24 hours

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

    24 hours

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

    24 hours

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

    24 hours

  • +4 more secondary outcomes

Study Arms (4)

EVP-6124 (0.1 mg/day)

EXPERIMENTAL
Drug: EVP-6124 (0.1 mg/day)Drug: DonepezilDrug: Rivastigmine

EVP-6124 (0.3 mg/day)

EXPERIMENTAL
Drug: EVP-6124 (0.3 mg/day)Drug: DonepezilDrug: Rivastigmine

EVP-6124 (1.0 mg/day)

EXPERIMENTAL
Drug: EVP-6124 (1.0 mg/day)Drug: DonepezilDrug: Rivastigmine

Placebo

PLACEBO COMPARATOR
Drug: Comparator: PlaceboDrug: DonepezilDrug: Rivastigmine

Interventions

EVP-6124 (0.1 mg/day)DRUG

EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.

EVP-6124 (0.1 mg/day)
EVP-6124 (0.3 mg/day)DRUG

EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.

EVP-6124 (0.3 mg/day)
EVP-6124 (1.0 mg/day)DRUG

EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.

EVP-6124 (1.0 mg/day)
Comparator: PlaceboDRUG

Matching placebo was administered as one capsule per day for 28 days.

Placebo
DonepezilDRUG

Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.

EVP-6124 (0.1 mg/day)EVP-6124 (0.3 mg/day)EVP-6124 (1.0 mg/day)Placebo
RivastigmineDRUG

Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.

EVP-6124 (0.1 mg/day)EVP-6124 (0.3 mg/day)EVP-6124 (1.0 mg/day)Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and post-menopausal or surgically sterile female pts
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pacific Research Network, Inc.

San Diego, California, 92103, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Global Medical Institutes, LLC

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCentral Nervous System Diseases

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamideDonepezilRivastigmine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsPhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic Acids

Results Point of Contact

Title
Maria Gawryl, Ph.D., Vice President, Regulatory Affairs & Drug Development
Organization
EnVivo Pharmaceuticals, Inc.
mgawryl@envivopharma.com
617-225-4264

Study Officials

  • David R. Hassmann, D.O.

    Comprehensive Clinical Research

    PRINCIPAL INVESTIGATOR

  • Beth Safirstein, M.D.

    MD Clinical

    PRINCIPAL INVESTIGATOR

  • Stephen Thein, Ph.D.

    Pacific Research Network, Inc.

    PRINCIPAL INVESTIGATOR

  • Jeffrey Apter, M.D.

    Global Medical Institutes

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 3, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 20, 2012

Results First Posted

July 14, 2011

Record last verified: 2012-04

Locations

US(4)