Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

ADHD has been associated with persistent deficits in the efficient allocation of attention and supports the notion that regulation of the cholinergic system may improve these cognitive deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent theory proposes that the cholinergic system allocates additional attentional resources during tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno 1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result in improved cognitive performance particularly on tests requiring effortful processing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Targacept Inc.

Criteria

Inclusion Criteria:

1. Diagnosis of ADHD per DSM-IV TR criteria

2. Score > 2 on at least 6 of 9 items in at least 1 subscale of the CAARS-INV

3. Score > 4 (at least moderate) on the Clinical Global Impression-Severity (CGI-S) index

4. Age 18 - 65, male or female

5. Tobacco non-users as indicated by lack of tobacco use within the last year prior to Screening, and by negative urinary cotinine level of < 50ng/mL after quantification

6. Able to understand and sign informed consent

Exclusion Criteria:

1. Current DSM-IV Axis I psychiatric disorder other than ADHD; use of MINI to exclude other major DSM-IV TR psychiatric diagnoses

2. Known or suspected drug abuse within the last 12 months prior to Screening

3. Urine drug screen positive for illegal or non-prescribed drugs at Screening

4. Patients at imminent risk of suicide or of danger to themselves or others

5. Use of drugs affecting cognitive function within 3 weeks prior to Day 1, including use of any medications for treatment of ADHD. Any medication wash-outs must be completed during the 3 weeks between Screening and Day 1.

6. Any other restricted or prohibited drugs.

7. Other concomitant medications that have been changed within 4 weeks prior to Screening

8. Unable to comply with study procedures in opinion of investigator, including CogState ADHD test battery

9. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, CV, GI, or urological disorder; or diagnosis of major depressive disorder

10. Myocardial infarction within past year

11. Seizure disorder within past year

12. Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)

13. HbA1C > 7.4 at Screening

14. BMI < 15 or > 35; male weight < 100 lbs; female weight < 80 lbs.

15. Current TB or known systemic infection (HBV, HCV, HIV)

16. Clinically significant finding on physical exam

17. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450 (males) or QTcF > 480msec (females), and excluding LFTs > 1.5 times upper limits of normal

18. Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control

19. Women with a positive pregnancy test, or who are lactating

20. Participation in another clinical trial in last 3 months prior to Screening