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Completed

NCT Number: NCT00766363

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pacific Research Network, Inc., San Diego, California, United States

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About this study

This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medication (donepezil or rivastigmine).

Study drug will be supplied as capsules and will be orally administered once daily for a total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2 (two days before the first dose of study drug is administered) and will remain confined to the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety assessments, PK sampling, and cognitive testing will be performed inpatient and at each study visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVP-6124 (0.1 mg/day)

Drug

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

EVP-6124 (0.3 mg/day)

Drug

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

EVP-6124 (1.0 mg/day)

Drug

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

Comparator: placebo

Drug

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

Donepezil

Drug

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.

Rivastigmine

Drug

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.

Primary outcomes

  1. 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]

    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)

Secondary outcomes

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

    Time frame: 24 hours

    EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma

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

    Time frame: 24 hours

    EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma

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

    Time frame: 24 hours

    EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot

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

    Time frame: 24 hours

    Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124

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

    Time frame: 24 hours

    Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124

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

    Time frame: 24 hours

    Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124

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

    Time frame: 24 hours

    Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124

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

    Time frame: 24 hours

    Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124

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

    Time frame: 24 hours

    Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124

Sponsors and collaborators

Lead sponsor

FORUM Pharmaceuticals Inc

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2008
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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