Clinical trial NCT01137526 (phase 2, status: completed)
Conditions: alzheimer's disease
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: abt-384, donepezil, placebo
SMILES: CC(C)(N1CCN(CC1)C1=NC=C(C=C1)C(F)(F)F)C(=O)N[C@H]1C2CC3CC1C[C@@](C3)(C2)C(N)=O, O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. The subject and caregiver must voluntarily sign and date and informed consent. If the
             subject is not fully competent, full informed consent must be obtained from a legal
             representative and assent must be obtained from the subject.

          2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at
             Day-1.

          3. Subject meets the NINCDS/ADRDA criteria for probable AD.

          4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at
             Screening Visit 1.

          5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening
             Visit 1.

          6. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable
             medical conditions, the subject is generally in good health based on medical history,
             physical examination, vital signs, clinical lab tests and 12-lead ECG.

          7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.

          8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is
             using a barrier method of birth control.

          9. Subject has an identified reliable, caregiver (e.g., family member, social worker,
             nurse), who will provide support and ensure compliance with the study medication and
             procedures.

         10. Subject and caregiver are fluent in the language used for administration of the rating
             scales or cognitive tests and have sufficient visual, hearing and graphomotor skills
             to complete procedures.

        Exclusion Criteria:

          1. Subject has a known hypersensitivity or intolerance to donepezil that led to
             discontinuation or a known reported history of donepezil treatment failure.

          2. Subject is currently taking or has taken a medication for the treatment of AD or
             dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy
             for the treatment of AD or dementia.

          3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on
             either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to
             Screening Visit 1.

          4. In the opinion of the investigator, the subject has any clinically significant
             uncontrolled medical or psychiatric illness that would affect the safety of the
             subject.

          5. The subject has a current thyroid disease or history of thyroid disease, and is not
             currently being treated with a stable dose of thyroid replacement medication.

          6. For any reason the investigator considers the subject to be an unsuitable candidate to
             receive ABT-384 or donepezil.