Alzheimer Disease

For safety reasons the clinical trial will first enroll 14 subjects (7 patients and 7 healthy volunteers) for Group 1a receiving 26 mg TEP daily for 4 days with subsequent safety evaluation, based on adverse events and the safety parameters discussed in the protocol. A second set of patients (Group 1b), which will receive a higher dosage of 52 mg per day for 4 days will be enrolled optionally after recommendation to continue and subsequently treatment Group 2 with a treatment paradigm of 26 mg TEP daily for 54 days will start.
Subjects eligible for participation are subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to AD and healthy volunteers who fulfill all inclusion criteria and have none of the exclusion criteria present at screening.

Klinik für Psychiatrie und Psychotherapie Universitätsmedizin Göttingen

Zentralinstitut für seelische Gesundheit, Medizinische Fakultät Mannheim, Universität Heidelberg,

Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease (AD) in Comparison to Healthy Volunteers

An Open-label, Multicenter, Controlled Pharmaco-dynamic Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease in Comparison to Healthy Volunteers

To demonstrate a significantly increased efflux of Amyloid beta peptides from the brain into the bloodstream in subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to Alzheimer's Disease vs. healthy volunteers that is expected to be caused by the ABCC1 transporter-stimulating effect of thiethylperazine.

Changes in scores obtained in psychometric tests in newly diagnosed (within last 12 month) subjects with early-to-mild dementia due to AD vs. healthy volunteers as well as the analysis of their changes from baseline will be determined after treatment with thiethylperazine.

To assess the safety and tolerability of thiethylperazine in newly diagnosed (within last 12 month) subjects with early-to-mild dementia due to AD and to compare this profile with the outcome of a control group of healthy volunteers
Assessments:
Treatment-emergent Adverse Events (AEs) Treatment-emergent Serious Adverse Events (SAEs) Adverse Events leading to premature discontinuation of trial medication

To investigate the effect of thiethylperazine on CSF levels of phosphoTau181 and total Tau in subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to AD

Immungenetics AG

Study medication will be administered twice daily. Capsules of dronabinol will contain 2.5 mg per dose (5mg daily) during Week 1, then increase to 5 mg per dose (10mg daily) for Weeks 2 and 3.

Placebo medication will be administered twice daily.

Alzheimer's Disease

Dronabinol (Marinol®)

Placebo

Miami Jewish Health

Johns Hopkins University

McLean Hospital

Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD)

Pilot Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD)

All Adverse Events (AE) s occurring after randomization and during the 3-week treatment period, regardless of adherence to study treatment, will be recorded at all contacts.

Mclean Hospital

The Erchonia ALS Laser is a mains powered variable hertz laser device made up of five independent red laser diodes mounted in scanner devices and positioned equidistant from each other. Each scanner emits 7.5 milliwatts (mW) ± 1.0 mW 640 nanometers (nm) with a tolerance of ±10 nm of red laser light.

The Placebo Laser is identical in appearance and operation to the Erchonia ALS Laser but does not emit any therapeutic light.

The Erchonia ALS Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. The total energy delivered to the subject per procedure administration is 22.5 joules.

Erchonia ALS Laser

The Placebo Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. There is no energy delivered to the subject.

Placebo Laser

Pruebas Clinicas

Neocemod

An Evaluation of Low Level Laser Light Therapy on Improving the Symptoms of Alzheimer's Disease

An Evaluation of the Effect of the Erchonia ALS on Alzheimer's Disease

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) is a validated psychometric instrument to evaluate the following aspects of cognitive function: memory, attention, reasoning, language, orientation, ideational praxis and constructional praxis. Scores on the ADAS-cog range from 0-70 with higher scores indicating greater impairment. Therefore, a decrease in the ADAS-cog score from baseline to study endpoint indicates improved cognitive functioning and is positive for study success; whereas an increase in the ADAS-cog score from baseline to study endpoint reflects potential cognitive deterioration and is negative for study success. The minimal clinical important difference (MCID) on the ADAS-cog has been established as a 4 point change (decrease).

The Alzheimer's Disease Co-Operative Study-Activities of Daily Living Inventory (ADCS-ADL) is a validated tool to assess instrumental and basic activities of daily living (i.e. functional performance) of AD based on a structured interview of the study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; Therefore, an increase in the ADCS-ADL score from baseline to study endpoint indicates improved functioning and is positive for study success; whereas a decrease in the ADCS-ADL score from baseline to study endpoint reflects potential functional deterioration and is negative for study success. The minimal clinical important difference (MCID) on the ADAS-ADL has been established as a 2 point change (increase - improvement).

The Mini Mental State Examination (MMSE) tool evaluates five areas of cognitive function: orientation, registration, attention and calculation, recall and language. It is an 11-item tool with a maximum attainable score of 30. A total score of 23 or lower indicates cognitive impairment.
Lower scores indicate progressively greater impairment. Therefore, an increase in the MMSE score from baseline to study endpoint indicates improved cognition and is positive for study success; whereas a decrease in the MMSE score from baseline to study endpoint reflects potential cognitive deterioration and is negative for study success.

The subject's study partner is asked to indicate how satisfied he or she is with any change observed in the subject's day-to-day functioning following the study procedure administration phase. Responses are recorded on a 5-point scale from 'Very Satisfied' to 'Not at All Satisfied'. Higher ratings indicate greater satisfaction with the study outcome and are positive for study success. Lower ratings indicate lesser satisfaction with the study outcome and are negative for study success

Erchonia Corporation

Adverse Mental/Physical Effects of Low Dose S. Tortuosum.

One arm has subjects 3 weeks on Scelectium Tortuosum 25gm po/d then 3 weeks off and then 3 weeks on Placebo.
The other arm has subjects 3 weeks on placebo, then 3 weeks off and then 3 weeks on Scelectium Tortuosum 25mg po/d.

Scelectium Tortuosum

Michel A. Woodbury, MD

Safety Study of the Effect of Scelectium Tortuosum (as Zembrin®)in Aged Normals

9 wk, Randomized, 2-blind, Placebo-controlled, 2X2 Cross-over Phase 1 Study of 25 mg of Scelectium Tortuosum (as Zembrin®) in Aged Normals to Find Effects on Mental, Emotional and Cognitive Safety Measures and Cytokines.

CNS Vital Signs is a measure of cognitive functioning and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Side effects will be assessed four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

This specific suicide assessment questionnaire is given four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

It is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Height, weight, blood pressure, fat content are measured four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

A complete physical is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Urine is take to be analysed at every visit, and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the blood serum is taken again, the 2nd arm started and at the end of 3 weeks, it is repeated again. The urine is sent for analysis, drug screen and if a fertile female a pregnancy test.

These similar scales that measure psychosis and depression are administered at every visit, and are done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the questionnaires are repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

The Tower of London is a measure of cognitive functioning and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

This is a measure of cognitive functioning and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

It is a measure of cognitive functioning and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Blood serum taken at every visit, and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the blood serum is taken again, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Blood for complete metabolic panel, CBC, C-Reactive Protein is taken at every visit, and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the blood is taken again, the 2nd arm started and at the end of 3 weeks, it is repeated again.

Depression via the Hamilton Mood Questionnaire is assessed in every visit and is done four times, once before the first arm and repeated after the end of the first arm three weeks later. Then after a 3 week washout the measure is repeated, the 2nd arm started and at the end of 3 weeks, it is repeated again.

amyloid/opkast

Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease (AD) in Comparison to Healthy Volunteers

Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD)

An Evaluation of Low Level Laser Light Therapy on Improving the Symptoms of Alzheimer's Disease

Safety Study of the Effect of Scelectium Tortuosum (as Zembrin®)in Aged Normals

The Efficacy and Safety of ITF2357 in AIS

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