An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.

Official Title
-----------------
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: AZD3480
* Drug: AZD3480


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of DSM-IV ADHD Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV) Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test Exclusion Criteria: Current DSM-IV Axis I psychiatric disorder (other than ADHD) Current user of cigarettes or other nicotine-containing product. Slow metabolizers as indicated by CYP2D6 genotyping. Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br> <br> |
| Experimental: 2<br> | Drug: AZD3480<br>* Capsules 5 mg/day (once a day) for 2 weeks<br>|
| Experimental: 3<br> | Drug: AZD3480<br>* Capsules 50 mg/day (once a day) for 2 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV). |  | Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Scales (NIMH 1985) |  | Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15 | 
| CDR computerized cognitive battery |  | 2, 3, 5, 8, 10, 13, 15 | 
| CNRU computerized cognitive battery |  | 2, 3, 5, 8, 10, 13, 15 |