Clinical Study to assess the Safety And Efficacy Of Investigational Medicinal Product Azeliragon (TTP488) In Patients With Mild Alzheimer's Disease who have previously completed a Clinical Trial with Azeliragon (TP488)
- Conditions
- MedDRA version: 20.0 Level: PT Classification code 10012294 Term: Dementia of the Alzheimer's type, with delirium System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012296 Term: Dementia of the Alzheimer's type, with depressed mood System Organ Class: 10029205 - Nervous system disordersMILD ALZHEIMER'S DISEASEMedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: HLT Classification code 10012268 Term: Dementia (excl Alzheimer's type) System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012295 Term: Dementia of the Alzheimer's type, with delusions System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012293 Term: Dementia of the Alzheimer's type, uncomplicated System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: LLT Classification code 10001896 TTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-004065-27-GB
- Lead Sponsor
- vTv THERAPEUTICS LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
1. Successful completion of Study TTP488-301 through the Month 18 Visit without ongoing SAEs or history of serious adverse drug reactions during study TTP488-301.
2. Patients must enroll in the present study within 7 days of completion of study TTP488-301.
3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally authorized representative) and caregiver/informant has been informed of all pertinent aspects of the study. Participants must be able to provide assent (where this is in accordance with local laws, regulations and ethics committee policy) and assent may be re-evaluated during the study at regular intervals.
4. Participants and caregiver/informants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. The subject must have a reliable caregiver/informant with regular contact (i.e., 10 hours a week as a combination of face-to-face visits and telephone contacts are acceptable) who will facilitate the subject’s full participation in the study. Caregivers/informant must have sufficient subject interaction to be able to provide meaningful input into the rating scales administered in this study where caregiver/informant input is required, in particular the CDR and evidence of this should be documented in source documentation. Participants who reside in assisted living facilities are permitted provided that they meet caregiver/informant criteria.
6. Participants and caregiver/informants must be able to read, write, and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate psychometric testing.
7. Subject must be able to ingest oral medications.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 690
Participants presenting with any of the following will be excluded from participation in the study.
1. The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
2. Subjects with serious suicide risk. If there are yes” answers on items 4, 5 or on any behavioral question of the C-SSRS, a suicide risk assessment must be done by a qualified mental health professional with expertise in the evaluation of suicidality in the elderly (e.g., psychiatrist, geriatrician or neurologist specializing in treatment of patients with AD) to determine whether it is safe for the subject to participate in the study.
3. Subjects demonstrating a QTcF > 480 msec or a >45 msec increase from the TTP488-301 Baseline value based on the locally read ECG performed at the TTP488-301 Month 18 Visit (TTP488-303 Baseline). Participants with known history of bundle branch block (either right or left) are allowed if absolute QTcF value does not exceed 500 msec. Participants with a functioning pacemaker, indicated by an ECG displaying paced rhythm, are allowed with no QTc upper limit.
4. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may prevent the subject from completing the 2-year study or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to collect long-term safety and tolerability data ;<br> Secondary Objective: To evaluate the time course of the effect of azeliragon on the cognitive (ADAS-cog) and global functional outcome (CDR-sb) measures<br> <br> To evaluate the efficacy of azeliragon on measures of behavior, cognition, function, resource utilization, and quality of life<br> ;Primary end point(s): Adverse events, clinical safety laboratory tests, ECG, vital signs. ;Timepoint(s) of evaluation of this end point: As defined per protocol at 3 month spaced visits up to 2 years
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Slope of change over time in ADAS-cog, CDR-sb, MMSE, ADCS-ADL, and NPI scales.<br> <br> Change from Baseline in measures of behavior, cognition, and function<br> ;Timepoint(s) of evaluation of this end point: As defined per protocol at 3 month spaced visits up to 2 years