Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01690195
• Collaborator: (none)
• Enrollment: 343
• Locations: 39
• Arm: 1
• Duration (Months): 17
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: ABT-126	Phase 2

Detailed Description

This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.

Study Design

• Study Type: Interventional
• Actual Enrollment: 343 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-126 ABT-126 Open-label dose	Drug: ABT-126; See arm description

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Assessments up through 28 weeks]

   Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study

2. Laboratory Data [Assessments up through 28 weeks]

   Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens

3. Vital Signs [Assessments up through 28 weeks]

   Assessments include pulse, blood pressure and oral body temperature

4. Physical examinations [Assessments up through 28 weeks]

   An examination of bodily functions and physical condition

5. Brief Neurological examination [Assessments up through 28 weeks]

   Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station

6. Brief Psychiatric assessments [Assessments up through 28 weeks]

   Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors

7. Columbia-Suicide Severity Rating Scale [Assessments up through 28 weeks]

   The scale is designed to assess suicidal behavior and ideation

8. Cornell Scale for Depression in Dementia [Assessments up through 28 weeks]

   Assesses the signs and symptoms of major depression in patients with dementia

9. Electrocardiogram [Assessments up through 28 weeks]

   Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.

• The subject was randomized into Study M11-793 and completed dosing through Week 24 in that study.

• With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.

• If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least two years or is surgically sterile, then use of a barrier method of birth control is not required.

• The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

• The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures.

Exclusion Criteria:

• The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 that indicates the subject could become medically unstable during the current study.

• The subject is currently taking or is expected to be prescribed any excluded medications without the approval of Abbott medical monitor.

• The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study.

• The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.

• The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial.

• The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study.

• For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 84185	Long Beach	California	United States	90806
2	Site Reference ID/Investigator# 84183	San Francisco	California	United States	94109-4841
3	Site Reference ID/Investigator# 84187	Hamden	Connecticut	United States	06518
4	Site Reference ID/Investigator# 84178	Delray Beach	Florida	United States	33445
5	Site Reference ID/Investigator# 84180	Orlando	Florida	United States	32806
6	Site Reference ID/Investigator# 84186	West Palm Beach	Florida	United States	33407
7	Site Reference ID/Investigator# 84182	Elk Grove Village	Illinois	United States	60007
8	Site Reference ID/Investigator# 84181	Staten Island	New York	United States	10312
9	Site Reference ID/Investigator# 84179	Bennington	Vermont	United States	05201
10	Site Reference ID/Investigator# 84173	Gatineau		Canada	J9A 1K7
11	Site Reference ID/Investigator# 84174	Montreal		Canada	H3T 1E2
12	Site Reference ID/Investigator# 84177	Peterborough		Canada	K9H 2P4
13	Site Reference ID/Investigator# 84175	Toronto		Canada	M3B 2S7
14	Site Reference ID/Investigator# 84176	Verdun		Canada	H4H 1R3
15	Site Reference ID/Investigator# 84376	Dijon Cedex		France	21033
16	Site Reference ID/Investigator# 84373	Limoges Cedex		France	87042
17	Site Reference ID/Investigator# 84374	Paris Cedex 10		France	75475
18	Site Reference ID/Investigator# 84377	Paris		France	75013
19	Site Reference ID/Investigator# 84375	Toulouse Cedex 9		France	31059
20	Site Reference ID/Investigator# 84382	Berlin		Germany	14050
21	Site Reference ID/Investigator# 84380	Freiburg		Germany	79106
22	Site Reference ID/Investigator# 84383	Huettenberg		Germany	35625
23	Site Reference ID/Investigator# 84379	Mittweida		Germany	09648
24	Site Reference ID/Investigator# 84381	Munich		Germany	81675
25	Site Reference ID/Investigator# 84378	Schwerin		Germany	19053
26	Site Reference ID/Investigator# 84385	Athens		Greece	115 21
27	Site Reference ID/Investigator# 84388	Athens		Greece	151 25
28	Site Reference ID/Investigator# 84389	Athens		Greece	15123
29	Site Reference ID/Investigator# 84386	Haidari, Athens		Greece	12462
30	Site Reference ID/Investigator# 84390	Thessaloniki		Greece	570 10
31	Site Reference ID/Investigator# 84395	Belville		South Africa	7530
32	Site Reference ID/Investigator# 84391	Cape Town		South Africa	7405
33	Site Reference ID/Investigator# 84393	George		South Africa	6529
34	Site Reference ID/Investigator# 84394	Johannesburg		South Africa	2196
35	Site Reference ID/Investigator# 84392	Rosebank		South Africa	2196
36	Site Reference ID/Investigator# 84398	Bath		United Kingdom	BA1 3NG
37	Site Reference ID/Investigator# 84397	Glasgow		United Kingdom	G20 0XA
38	Site Reference ID/Investigator# 84400	London		United Kingdom	TW8 8DS
39	Site Reference ID/Investigator# 84399	Manchester		United Kingdom	M8 5RB

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Laura Gault, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01690195
• Other Study ID Numbers: M11-428; 2012-000537-39
• First Posted: Sep 21, 2012
• Last Update Posted: Aug 2, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Aug 2, 2021