NCT01254448

Brief Summary

This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

10 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

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

December 2, 2010

Last Update Submit

September 3, 2013

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Number of participants with treatment-emergent adverse events

    Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14

Secondary Outcomes (3)

  • Pharmacokinetic profiles

    Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

  • Markers of inflammation in cerebrospinal fluid

    Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

  • Markers of inflammation in plasma

    Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).

Drug: Placebo

TC-5619

EXPERIMENTAL

Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).

Drug: TC-5619

Interventions

TC-5619DRUG

Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.

TC-5619
PlaceboDRUG

Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.

Placebo

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal body mass index (BMI)
  • Non-smoking for a minimum of 3 months
  • Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG.
  • Group 1 Only:
  • Subjects a Mini Mental State Examination score between 12-22, inclusive.
  • Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Subjects must have a reliable caregiver.

You may not qualify if:

  • Subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (Group 1 subjects must have Alzheimer's Disease), or any other illness that could interfere with interpretation of study results.
  • Subjects with a past or current history of seizures cannot participate.
  • Current use of donepezil, rivastigmine or galantamine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Comprehensive Phase One

Miramar, Florida, 333025, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Atlanta Center For Clinical Research

Atlanta, Georgia, 30308, United States

Location

Princeton Medical Institutes

Princeton, New Jersey, 08540, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

N-(2-(pyridin-3-ylmethyl)-1-azabicyclo(2.2.2)oct-3-yl)-1-benzofuran-2-carboxamide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • George Gerson, MD

    Comprehensive Phase One

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 6, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

US(10)