Alcohol Use Disorder (AUD)

Magnetic resonance imaging (MRI) scans will be done to assess brain structure, functional reactivity and functional connectivity.

connectivity

The use of [11C] PBR28 will allow us to assess for the first time in vivo if there is neuroinflammation in the brain of alcoholics. It will also allow us to assess if it recovers with alcohol detoxification.

neuroinflammation

To assess regional brain glucose metabolism.

neurofunction

National Institutes of Health Clinical Center, 9000 Rockville Pike

Brain Inflammation and Function in Alcoholism

To assess if there is inflammation detected in the brain of alcoholics subjects as measured with [11C]PBR28 as compared to healthy controls.

To assess if there is neuroinflammation detected in the brain of alcoholics subjects as measured with [11C]PBR28 as compared to healthy controls and if it recovers with at least 3 weeks of abstinence.

We want to see whether [11C] PBR28 uptake in the brain reflects levels similar to controls after at least 3 weeks of alcohol abstinence.

to assess if neuroinflammation is associated with markers of brain function and to evaluate if neuroinflammation predicts relapse in AUD over a 3 month follow-up period.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Subjects in this group will receive 4 weeks of 8 mg/day galantamine CR, followed by 4 weeks of 16 mg/day and from week 9 up to the end of the trial of 24 mg/day.

Galantamine titration will be performed as described above. Memantine titration will be performed over 4 weeks in steps of 5 mg/day up to 20mg/day (10 mg b.i.d.). 50 % of this group will receive galantamine first, 50 % of the group will receive memantine first to allow for differential qualitative evaluation of tolerability of a combination therapy.

Alzheimer's Disease

24 mg/day with dose-titration over twelve weeks

Galantamine CR

memantine 10 mg b.i.d. with a dose titration of sixteen weeks

Memantine

Placebo will be similar in appearance to Memantine

Placebo

The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease

Competence Network - Dementia (BMBF) "Pharmacological and Psychosocial Treatment" (Modul E.2) Part II: The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease

Alzheimer's Disease Assessment Scale (ADAS-cog/11) The ADAS consists of two parts - a cognitive subscale and a behavioral subscale. The behavioural subscale will not be used in this trial. The cognitive subscale, the ADAS-cog/11, consisting of Word Recall and Word Recognition memory tests, Object and Finger Naming, Commands, Constructional Praxis, Ideational Praxis, Orientation, Remembering Test Instructions, Spoken Language Ability, Comprehension of Spoken Language and Word Finding Difficulty will be the primary variable in this trial. In this trial the German version of the ADAS-cog/11 will be employed (Ihl & Weyer, 1993).

The ability to perform activities of daily living will be assessed using the AD version of the Alzheimer's Disease Cooperative Study ADL inventory (Galasko et al., 1997, 2004). This instrument comprises questions about 23 basic and instrumental ADLs. For each ADL, the scores range from 0 (non-performance of the activity or the need for extensive help) to the highest score (representing independent performance of the activity). The total score ranges from 0 (no function) to 78 (maximal function).

The CDR Scale is a clinician-rated dementia staging system that tracks the progression of cognitive and functional deterioration. Scores are on a scale of 0 - 5, with 0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia, 4 = profound dementia, and 5 = terminal dementia. Cognitive and functional abilities that are assessed are memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care. Memory is considered the primary driver for scoring with the other categories secondary.

The Neuropsychiatric Inventory (Cummings et al., 1994) is used to assess 10 areas of non-cognitive symptoms which are common in dementia, including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The NPI uses a screening strategy to minimize administration time. Interrater reliability and test-retest reliability are acceptable.

For each patient, use of medical and social services will be determined using the Resource Utilization of Dementia Scale (Wimo et al., 1998). This instrument is used to rate the primary caregiver (time spent on caring, occupational status, use of medical and social services, use of medications) and the patient (living arrangement, nursing home and hospital admissions, use of medical and social services) to estimate healthcare cost

The Burden Interview (Zarit & Zarit, 1983, 1990) has been designed to assess the stress experienced by family caregivers of elderly and disabled persons. It can be completed by caregivers themselves or as part of an interview. Caregivers are asked to respond to a series of 22 items about the impact of the patient's disabilities on their life. For each item caregivers are to indicate how often they have felt that way: never, rarely, sometimes, quite frequently, or nearly always.
The Burden Interview is scored by summing the responses of the individual items. The total score ranges from 0 to 88. Higher scores indicate greater caregiver distress.

Serial volumetric MRI will generate data-sets used for whole brain rate of atrophy determinations, hippocampal rate of atrophy measurements as well as MR-spectroscopic parameters

inositol/атрофия

Brain Inflammation and Function in Alcoholism

The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease

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