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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01548430

Run by

vTv Therapeutics

People needed

8

Starts

2011-10-01

Expected to finish

2013-02-01

Last updated by the study team

2015-02-12

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Miami, Florida, United States
• Study site — Durham, North Carolina, United States
• Study site — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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