Phase
Condition
Dementia
Neurologic Disorders
Multiple Sclerosis
Treatment
DAAOI-P
Placebo
Clinical Study ID
Ages 50-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- PD-D will be diagnosed according to the criteria proposed by Movement DisorderSociety task force statement. (Emre et al. 2007) . The following wordings aremodified from the task force statement. I. Core features
Diagnosis of PD according to Queen Square Brain Bank criteria
A dementia syndrome with insidious onset and slow progression, developingwithin the context of established PD and diagnosed by history, clinical, andmental examination, defined as:
- Impairment in more than one cognitive domain
- Representing a decline from premorbid level
- Deficits severe enough to impair daily life, independent of the impairmentascribable to motor or autonomic symptoms
- MMSE score between 10-26.
II. Associated clinical features
Cognitive features: Impaired attention, executive functions, visuo-spatial functionsor memory. Core functions of language are largely preserved.
Behavioral features:
Apathy
Changes in personality and mood
Hallucination• Delusions
Excessive daytime sleepiness
III. Features which do not exclude PD-D, but make the diagnosis uncertain
Co-existence of any other abnormality which may by itself cause cognitiveimpairment, but judged not to be the cause of dementia.
Time interval between the development of motor and cognitive symptoms is uncertain
IV. Features suggesting other conditions or diseases as cause of mental impairment, which, when present make it impossible to reliably diagnose PD-D
- Cognitive and behavioral symptoms appearing solely in the context of otherconditions such as:
Acute confusion due to systemic illnesses or drug intoxication.
Major depression
- Features compatible with "Probable Vascular dementia" criteria according toNINDS-AIREN Criteria for the diagnosis of probable and possible PD-D [Probable PD-D]Both core features must be present. In associated clinical features, typical profileof cognitive deficits should be present in at least 2 of the 4 core cognitivedomains. The presence of at least one behavioral symptom supports the diagnosis ofprobable PD-D. None of group III and IV features is present. [Possible PD-D] Bothcore features must be present. In associated clinical features, the cognitiveimpairment is atypical in one or more domains. The behavioral symptoms are notnecessary to be present. One or more of the group III features may be present. Nogroup IV feature is allowed to be present.
Exclusion
Exclusion Criteria:
Patients with uncontrollable malignancy, severe heart failure, uremia underhemodialysis, or decompensated liver cirrhosis.
Patients taking anticholinergics within 30 days of recruitment.
Study Design
Study Description
Connect with a study center
Department of Psychiatry, China Medical University Hospital
Taichung,
TaiwanActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.