A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01548430 |
Recruitment Status :
Completed
First Posted : March 8, 2012
Last Update Posted : February 12, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: TTP4000 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: TTP4000 1.0 mg/kg
Administered subcutaneously
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Drug: TTP4000 |
Experimental: TTP4000 3.0 mg/kg
Administered subcutaneously
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Drug: TTP4000 |
Placebo Comparator: Placebo
Administered subcutaneously
|
Drug: Placebo |
- Number of participant with adverse events [ Time Frame: Day 0 to Day 84 ]
- Evaluation of participant plasma TTP4000 concentrations [ Time Frame: Day 0 to Day 84 ]

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548430
United States, Florida | |
Miami, Florida, United States | |
United States, North Carolina | |
Durham, North Carolina, United States | |
High Point, North Carolina, United States |
Study Director: | Robert Hernandez, Ph.D. | TransTech Pharma, Inc. |
Responsible Party: | vTv Therapeutics |
ClinicalTrials.gov Identifier: | NCT01548430 |
Other Study ID Numbers: |
TTP4000-101 |
First Posted: | March 8, 2012 Key Record Dates |
Last Update Posted: | February 12, 2015 |
Last Verified: | February 2015 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |