A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

vTv Therapeutics

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: TTP4000

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548430

TTP4000-101

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 3 patient groups, including a placebo group

TTP4000 1.0 mg/kg

Experimental group

Description:

Administered subcutaneously

Treatment:

Drug: TTP4000

TTP4000 3.0 mg/kg

Experimental group

Description:

Administered subcutaneously

Treatment:

Drug: TTP4000

Placebo

Placebo Comparator group

Description:

Administered subcutaneously

Treatment:

Drug: Placebo