CompletedPhase 1

Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease

Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease

Lead sponsor

Targacept Inc.

Asset

TC-5619

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-22•Study partner/caregiver required

Primary endpoint

•Adverse Events as a Measure of Safety and Tolerability

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

NCT IDNCT01254448

Org study IDTC-5619-238-CLP-003

Timeline

Milestones

Study start2010-09 (month precision)

Study first posted2010-12-06estimated

Primary completion2011-03actual (month precision)

Study completion2011-05actual (month precision)

Last update posted2013-09-04estimated

Assets

Drug assets

TC-5619

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

(Groups 1 \& 2):

•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

Exclusion criteria

(Groups 1 \& 2):

•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.

Endpoints (4)

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

Safety / tolerability / PK

Fluid / digital biomarkers

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Markers of inflammation in cerebrospinal fluid

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

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

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

event count, event

Secondary/protocol endpoint

Pharmacokinetic profiles

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

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Markers of inflammation in plasma

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

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.