Alzheimer's Disease
Conditions
Brief summary
The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.
Interventions
DRUGTTP4000
DRUGPlacebo
Sponsors
vTv Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Males or females ≥ 50 years of age. * Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. * Weight ≥ 50 kg. * Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam. * Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.
Exclusion criteria
* Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder. * Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participant with adverse events | Day 0 to Day 84 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of participant plasma TTP4000 concentrations | Day 0 to Day 84 |
Countries
United States
Outcome results
None listed